BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4144265 · Received October 6, 2014

    Report

    Report Number
    2124215-2014-17726
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT-OF-RANGE (OOR)PACING IMPEDANCES OF GREATER THAN 2000 OHMS, AS WELL AS LOSS OF CAPTURE (LOC), NOISE, OVERSENSING WHICH LED TO PACING INHIBITION. THE LEAD WAS FOUND TO BE FRACTURED AND HAD DAMAGED INSULATION. THESE ISSUES LED TO THE PREMATURE DEPLETION OF THE ICD. THE DEVICE WAS EXPLANTED, AND THE LEAD WAS SURGICALLY ABANDONED AND BOTH WERE SUCCESSFULLY REPLACED. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623596 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R 0293| N119| 4592| N140| 4543| 4136| T175| 0185