BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR CPX 3

    MDR report key: 5252983 · Received November 23, 2015

    Report

    Report Number
    MW5058148
    Event Type
    Injury
    Date Received
    November 23, 2015
    Date of Event
    November 5, 2014
    Report Date
    November 23, 2015
    Manufacturer
    MENTOR
    Product Code
    LCJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    1

    Narratives

    Description of Event or Problem · 1

    A (B)(6) WOMAN WITH AN ICD (MEDICAL PROTECTA XT PLACED IN 2004) AND A MENTOR CPX 3 BREAST TISSUE EXPANDER (BTE) PLACED IN 2013 PRESENTED WITH INTERACTION BETWEEN THE MAGNET IN THE BTE AND THE DEFIBRILLATOR. THE BTE HAD BEEN IMPLANTED AFTER MASTECTOMY FOR BREAST CANCER, ABOUT 9 YEARS AFTER THE ICD. BOTH THE BTE AND THE ICD WERE IMPLANTED IN THE LEFT PECTORAL AREA. THE BTE WAS BEING EXPANDED GRADUALLY WITH SALINE INJECTIONS. AFTER SEVERAL EXPANSIONS, THE PATIENT NOTICED THAT HER ICD WAS BEEPING EVERY SECOND FOR ABOUT 30 SECONDS. THIS HAPPENED SEVERAL TIMES. SHE WAS INSTRUCTED TO GO TO THE EMERGENCY ROOM. INTERROGATION OF THE ICD REVEALED THAT RECURRENT INTERACTION WITH THE MAGNET FROM THE BTE RESULTED IN TRANSIENT INACTIVATION OF PROGRAMMED TACHY THERAPIES (SHOCKS, ANTI-TACHYCARDIA PACING). THIS WAS A POTENTIALLY LETHAL ADVERSE EFFECT IF THE PATIENT WERE TO DEVELOP VENTRICULAR FIBRILLATION DURING THE TIME WHEN THE ICD THERAPIES WERE TURNED OFF BY THE MAGNET. THE BTE WAS REMOVED. NO OTHER ADVERSE EFFECTS OCCURRED. MORE DETAILS CAN BE FOUND IN THE CASE REPORT WE PUBLISHED ONLINE: AGRWAL S, VERMA N, KIM JYS, KNIGHT BP, CHICOS A. A CURIOUS CASE OF BREAST TISSUE EXPANDER. ARRHYTHMIA GRAND ROUNDS 2015; 1(2) : 56-57. DOI: HTTP://DX.DOI.ORG/10.12945/J.AGR.2015.019-14. IMPORTANTLY, THIS INTERACTION CAN HAPPEN WITH BREAST TISSUE EXPANDERS THAT INCLUDE MAGNETS FROM OTHER MANUFACTURERS (ALLERGAN). THE BTE DEVICE INSERT STATES THAT IT IS CONTRAINDICATED IN PATIENT WHO HAVE PACEMAKERS, BUT DOES NOT SPECIFY DEFIBRILLATORS. THE INTERACTION WITH DEFIBRILLATORS (MAGNET TURNS OFF TACHYARRHYTHMIA THERAPIES) IS ACTUALLY MUCH MORE SIGNIFICANT THAN THE INTERACTION WITH PACEMAKERS (MAGNET SWITCHES PACING TO ASYNCHRONOUS MODE). REASON FOR USE: ADJUSTABLE BREAST TISSUE EXPANDER. EVENT ABATED AFTER USE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772635 MENTOR CPX 3 MENTOR CPX 3 LCJ MENTOR MENTOR CPX3

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention