After Fixing Battery Defect, St. Jude Continued to Sell Older Pacemakers

St. Jude Medical is facing criticism regarding certain models of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). These heart devices deliver electrical shocks or pacing in patients. Recently, certain models of the Fortify, Unify and Assura ICD and CRT-D were recalled due to a defect that could cause early battery depletion. Premature battery failure can lead to loss of therapy, which can cause patient death. The early battery defect with St. Jude defibrillators has been linked to two deaths so far. The recall has been given a Class I designation by the U.S. Food and Drug Administration (FDA).

Now, it appears that St. Jude is being scrutinized for continuing to sell older versions of the pacemakers after correcting the battery defect. StarTribune reports that the company implemented a design change to address the battery failure defect, but continued to sell out ICDs and CRT-Ds with the old battery. While the FDA did not initially require St. Jude to recall heart devices with the older version of the battery, some physicians are saying that the decision to leave them on the shelves was unethical. Parker Waichman personal injury lawyers are continuing to monitor these events. The firm offers free legal case evaluations to individuals who have questions about St. Jude Medical defibrillator injuries.

St. Jude Continued to Sell Old Versions of Heart Devices

According to StarTribune, St. Jude made a design improvement that addressed the battery defect in May 2015. However, the company acknowledged that it continued to sell the older versions of the battery with its ICDs and CRT-Ds for another 17 months. St. Jude first found out about the battery defect in December 2014 through a journal article, and implemented the design change to address the risk of a lithium-related short circuit. Ultimately, the battery defect led to a recall of certain models of the Fortify, Unify and Assura.

The premature battery depletion stems from a buildup of lithium between the anode and the cathode, the two main components of the battery. If this occurs, it can cause the battery to deplete rapidly. The May 2015 design change added an internal barrier to the insulation inside the battery to reduce the risk of lithium deposit causing a short circuit.

Issues with the older version of the battery ultimately led to a recall affecting 350,000 devices worldwide. In the United States, 199,642 defibrillators are affected. St. Jude claims that when it changed the design, the company had no way of knowing the issue would become so widespread.

The decision not to take older versions of ICDs and CRT-Ds off the shelves is being criticized by some physicians. Since doctors learned of the recall at almost the same time as the public, older versions were continuing to be implanted. “I’m very angry because those patients put their lives in my hands,” said Dr. Kevin Campbell, a cardiac electrophysiologist in North Carolina to StarTribune. “If it’s a big-enough deal to change the manufacturing process, then pull it off the shelf.”

When St. Jude first changed the design of the battery, the FDA did not mandate a recall. “Available data available regarding the rate of overall adverse events indicated the risk to patients was low and was considered consistent with overall rates observed with other makes and models of implantable defibrillators,” explained FDA spokeswoman Deborah Kotz to Qmed. “Manufacturers are not required to initiate a device recall for changes to medical devices that are not in violation of the Federal, Food, Drug and Cosmetic Act (FD&C Act).”

Class I Recall Issued for Pacemakers Due to Early Battery Failure

According to an Oct. 11 FDA safety communication, a Class I recall was issued for St. Jude Medical ICDs and CRT-Ds. Class I recalls are the most serious recall status, indicating that the recalled device presents a reasonable risk of serious injury or death. The heart devices are implanted under the skin in the upper chest. ICDs can deliver an electrical shock while CRT-Ds can provide shocks or act as a pacemaker. The implantable defibrillators deliver therapy when patients have a dangerously fast or slow heart rhythm.

Certain models of the Fortify, Unify and Assura ICDs and CRT-Ds were recalled because the battery may deplete sooner than expected due to lithium buildup. “If the battery unexpectedly runs out before the patient is aware of the rapid battery drain and able to have it replaced, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death.” the FDA recall alert notes.

Due to rapid battery depletion, patients and caregivers are urged to replace batteries as soon as the Elective Replacement Indicator (ERI) alerts go off. Under normal circumstances, the battery will last another three months following the ERI alert. With the early depletion defect, however, the battery can drain much sooner. St. Jude is aware of reports where the battery depleted within 24 hours of the ERI.

According to the FDA alert, 841 devices were returned for analysis due to early battery failure. The agency says the ICDs and CRT-Ds were linked to two deaths; because the battery was prematurely drained, these patients did not receive the necessary shock therapy. The heart devices were also linked to 10 reports of patients fainting and 37 reports of dizziness.

Since removing the ICDs and CRT-Ds can present new complications, the FDA advised home monitoring for most patients. The decision to remove the defibrillators should be determined by the physician based on the patient’s individual situation, the FDA said.

According to the FDA, the following devices are affected by the recall:

  • Fortify VR: Model No(s). CD1231-40, CD1231-40Q
  • Fortify ST VR: Model No(s). CD1241-40, CD1241-40Q
  • Fortify Assura VR: Model No(s). CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q
  • Fortify Assura ST VR: Model No(s). CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q
  • Fortify DR: Model No(s). CD2231-40, CD2231-40Q.
  • Fortify ST DR: Model No(s). CD2241-40, CD-2241-40Q, CD2263-40, CD2263-40Q
  • Fortify Assura DR: Model No(s). CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q
  • Fortify Assura ST DR: Model No(s). CD2363-40C, CD2363-40Q
  • Unify: Model No(s). CD3231-40, CD3231-40Q
  • Unify Quadra: Model No(s). CD3249-40, CD3249-40Q
  • Unify Assura: Model No(s). CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q
  • Quadra Assura: Model No(s). CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q
  • Quadra Assura MP: Model No(s). CD3269-40, CD3269-40Q, CD3369-40C

St. Jude ICD and CRT-D Lawsuits

Parker Waichman injury lawyers are offering free, no obligation legal consultations to individuals who have questions about St. Jude ICD and CRT-D lawsuits. The firm is investigating allegations that St. Jude failed to warn consumers and the medical community about the risk of early battery depletion. If you or someone you know suffered an adverse event related to premature battery failure with various models of the Fortify, Unify or Assura, email us , or calling 1-800-YOURLAWYER (1-800-968-7529).

Save

This entry was posted in Defective Medical Devices, St. Jude Defibrillators and tagged , , , , . Bookmark the permalink.


© 2005-2017 Parker Waichman LLP ®. All Rights Reserved.