Medtronic EnTrust Implantable Cardioverter Defibrillators (ICDs) have been recalled in the U.K., the Medicines and Healthcare products Regulatory Agency (MHRA) just announced. Medtronic issued a Field Safety Notice addressing this issue on March 6, 2012.
A risk of loss of ICD/pacing therapy, after the elective replacement indicator (ERI) is reached, occurs due to rapid battery depletion after about 2 ½ years following implantation. Medtronic EnTrust models involved are D153ATG, D153DRG, D153VRC, D154ATG, D154DRG, and D154VRC.
In the event of a battery short circuit, the ICD may be unable to provide the required therapy for the three-month period generally expected post-ERI; however, incidents of charge circuit timeout have occurred. To date, there have been no reports of death or serious injury associated with this failure.
The rapid voltage drop has been linked to an internal short circuit within the ICD battery; the exact root cause is under investigation by the manufacturer and the issue appears to be specific to EnTrust devices. Failure rate data for other Medtronic ICD models incorporating the same battery model currently indicate that they are not affected. These batteries are not used by other manufacturers
The MHRA urges all cardiologists and cardiac physiologists who manage patients implanted with the recalled Medtronic EnTrust ICDs to follow-up with those patients implanted with the ICDs either within one month, if the recalled device was implanted for more than 28 months, or within three months in all other cases. Physicians should ensure audible alerts for “Low Battery Voltage ERI” and “Excessive Charge Time EOL” are programmed as “ON.” The status can be viewed over Medtronic’s CareLink program.
Patients and health care providers should contact their areas’ adverse incident reporting center immediately if the alert sounds. Battery voltage values should be compared from prior follow ups to determine if a rapid battery voltage drop occurred.
ICDs should be replaced in cases in which the ERI has been reached when a rapid battery voltage drop took place in the preceding two-week period. Prophylactic replacement of these recalled devices is not recommended, except under exceptional circumstances, said the MHRA.
About 69,000 EnTrust devices have been sold worldwide since 2005. To date, 0.15% of single chamber EnTrust ICDs and 0.04% of dual chamber EnTrust ICDs, worldwide, reportedly experienced rapid voltage decline. The issue does not appear to affect devices implanted for less than 30 months and the failure rate as implant duration increases is not yet known.
Medtronic Limited can be reached, via Mrs. Lezlie Bridge, by telephone in the U.K. at 01923 212 213 / 07740 899 216, by fax at 01923 225 273, or by email to lezlie.j.bridge@medtronic.com.
