—#167203

Product

ACCOLADE Pacemaker

FDA product code: LWS — Implantable Cardioverter Defibrillator (Non-Crt)
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P150012
Affected lot / code info: ACCOLADE SR model L300, ACCOLADE DR model L301, ACCOLADE MRI SR model L310, ACCOLADE MRI DR model L311, ACCOLADE EL DR model L321 and ACCOLADE MRI EL DR model L331.

Why it was recalled

Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.

Root cause (FDA determination)

Component design/selection

Action the firm took

On September 2018 Boston Scientific sent letters to their customers with the following information: Dear Doctor, Boston Scientific has identified a subset of approximately 2,900 active ACCOLADE", PROPONENT", and ESSENTIO" pacemakers and VISIONIST" and VALITUDE" cardiac resynchronization therapy pacemakers (CRT-Ps) with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion. There have been no reports of injury related to this behavior. You are receiving this letter because you or your center has implanted or follow one or more patients with a pacemaker in this subset. This device behavior can be identified via the regular pacemaker follow-up process, either in-clinic or through the LATITUDE" NXT Remote Patient Management System (LATITUDE). Therefore, a follow-up interval of no more than six (6) months is recommended and is consistent with existing international societal guidelines1. If accelerated depletion is suspected, Boston Scientific recommends consultation with Technical Services to review the pacemaker diagnostic data available from either a recent data upload in LATITUDE or a Save to Disk to confirm accelerated depletion and determine an appropriate timeframe for pacemaker replacement. Description The pacemaker manual describes how increases in pacing requirements or changes in programmed parameters may result in an expected longevity reduction and are considered normal battery depletion. However, hydrogen exposure within the pacemakers circuitry may compromise the electrical performance of low voltage capacitors causing current leakage and a moderate acceleration in the rate of battery depletion. Because this accelerated depletion does not occur rapidly, a follow-up interval of no more than six months is recommended. Boston Scientific has determined a liner component to be the source of hydrogen and identified a subset of previously distributed pacemakers that have an elevated potential for exh

Recalling firm

Firm: Boston Scientific Corporation
Address: 4100 Hamline Ave N, Bldg 3, Saint Paul, Minnesota 55112-5700

Distribution

Distribution pattern: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, W A, WI, WV, and WY

Timeline

Recall initiated: 2018-09-10
Terminated: 2019-11-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #167203. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.