Medtronic, Evera Implantable Cardioverter Defibrillators: Product Model EVERA XT DDBB1D1, DDBB1D4, DDBB2D1, DDBB2D4, DVB

FDA device recall Z-2651-2016 · posted 2016-08-25 · Terminated

Recall details

Recalling firm

Medtronic Inc., Cardiac Rhythm and Heart Failure

Reason for recall

78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a low resistance path developing within the circuit component. There have been seven (7) confirmed failures (9%) through July 16, 2016. Reported complications have included shortness of breath, pocket heating, low heart rate, and early device explant.

Action taken

Consignees were sent or hand delivered on August 12, 2016 a Medtronic "Urgent Medical Device Correction" letter dated August 2016. The letter was addressed to Physician. The letter described the problem and the devices involved in the recall. The letter described a number of "Patient Management Recommendations". For questions contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LWS

Quantity affected

78 (39 US, 39 OUS)

Distribution

Worldwide Distribution - US Nationwide in the states of US: AZ, CA, FL, GA, IL, KY, MD, MN, NJ, NY, NC, OH, OK, PA, PR, TX. and countries of: Australia, Finland, France, Germany, Iran, Italy, Japan, K

Date initiated

2016-08-12

Date posted

2016-08-25

Date terminated

2017-01-20

Location

Mounds View, MN