Medtronic has issued a recall for about 96,800 InSync III pacemakers because of a battery defect that may prevent the device from operating properly, endangering the patient.
The recall covers three different pacemaker models. In a letter to doctors, Medtronic wrote that 30 of the devices have been demonstrated to have a problem with long-term battery performance, which could prevent the devices from supplying enough electrical current for normal operation, Qmed reports.
The battery problem could cause a variety of problems including the unexpected loss of pacing capture, erratic behavior, fluctuations in longevity estimates, and inaccurate lead impedances, according to Qmed. At least 22,000 of the InSync III pacemakers remain implanted in patients worldwide.
The recall relates affects more than 9,300 devices in the United States and has been designated a Class 2 recall by the Food and Drug Administration (FDA). In a Class 2 recall, the FDA judges that there is no immediate danger of death or other serious injury linked to the product, but the risk of death or a serious injury is still present.
The company has received a report of one patient death where the battery problem may have been a contributing factor, Qmed reports. In a letter to patients, Medtronic wrote, “if pacing capture is compromised, some patients may experience a return of heart failure symptoms due to loss of biventricular pacing. In cases involving pacemaker-dependent patients, a loss of pacing capture could result in serious injury or death.” The recall is being handled by Medtronic’s cardiac-device business in Mounds View, Minnesota.
In its letter to physicians, Medtronic says, “it is not possible to identify which devices might fail or when they might fail. The issue cannot be mitigated by programming changes or increasing patient follow-up frequency.” Medtronic said it will offer customers a supplemental warranty and will continue to monitor device performance.
The devices have an expected battery life of 5.8 to 7.5 years, depending on how the doctor programs the device settings, the StarTribune reports. The paper also reports that the Minneapolis Heart Institute has contacted its InSync III patients about their options, which include early replacement of the InSync III. The letter advised patients that lightheadedness or fainting may be signs that the pacemaker is not working properly.