This month, St. Jude Medical issued a recall of certain cardiac defibrillators (see list below) because of “reports of rapid battery failure caused by deposits of lithium (known as ‘lithium clusters’), forming within the battery, and causing a short circuit,” according to the FDA, which classified the recall as Class 1, the most serious type. The result could be fatal, according to the FDA:

“If the battery unexpectedly runs out before the patient is aware of the rapid battery drain and able to have it replaced, the ICD [implantable cardioverter defibrillator] or CRT-D [cardiac resynchronization therapy defibrillator] will be unable to deliver life-saving pacing or shocks, which could lead to patient death.”

As of the date of the recall, of the 398,740 affected devices sold worldwide, 841 were returned for analysis due to premature battery depletion caused by lithium clusters.

  • 2 deaths (1 in the U.S.), have been associated with devices that could not provide needed shock therapy due to premature battery depletion.
  • 10 patients (9 in the U.S.), have reported fainting from devices that could not provide needed pacing therapy due to premature battery depletion.
  • 37 patients (30 in the U.S.), have reported dizziness from devices that could not provide needed pacing therapy due to premature battery depletion.

The models involved include Fortify™, Fortify Assura™, Quandra Assura™, Unify™, Unify Assura™ and Unify Quadra™ ICDCRT-D devices. According to the company, “an analysis found that some devices manufactured prior to May 23, 2015, contain batteries which may run out of energy earlier than expected. This is termed: ‘premature battery depletion’.”

October 2016 Recall Involves Defibrillators Manufactured before May 2015

The recalled devices were manufactured from January 2010 to May of 2015. They were distributed from February of 2010 to October of 2016.

An article in the Star Tribune looks at the timing of the recall:

“Although St. Jude had fixed the problem that led to a recall of the devices back in 2015, the company kept selling its stock of older units” (Star Tribune).

We recommend you read the full article, written by Joe Carlson, which includes interviews of patients.

Patients need an ICD or CRT-D if their heart beat is too slow (bradycardia), too fast (tachycardia), or needs coordination to treat heart failure. St. Jude’s recommending home monitoring with a [email protected] device; however, the FDA warns of cybersecurity vulnerabilities:

“The FDA (in partnership with the Department of Homeland Security ICS-CERT) continues to investigate recent allegations of cybersecurity vulnerabilities associated with St. Jude Medical cardiac devices, including the [email protected] monitoring system. Despite the allegations, at this time, the FDA strongly recommends that the [email protected] device be used to monitor the battery for these affected devices. The ICD and CRT-D devices identified in this safety communication provide life-saving therapy, and the FDA believes that the benefits of monitoring outweigh any potential cybersecurity vulnerabilities.”

What Devices Have Been Recalled?

The following St. Jude Medical defibrillators are part of the October 2016 recall of about 251,346 devices in the United States:

  • 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

FDA Safety Communication

St. Jude Medical has reported that in some cases, full battery drainage can occur within a day to a few weeks after the patient receives an ERI alert, according to an FDA Safety Communication:

“If the battery runs out, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death. The patients most at risk are those with a high likelihood of requiring life-saving shocks and those who are pacemaker dependent.”

“Battery depletion may not always be reported to the manufacturer, therefore the true number of devices with premature battery depletion due to lithium clusters is not known. At this time, 349,852 affected devices remain actively implanted worldwide.”

In the Communication, the FDA acknowledges that there is a risk of complications from revision surgery to replace a recalled defibrillator. The agency also acknowledges patients who are dependent on a pacemaker may need this surgery.

Bad Bug Law Team Pritzker