BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 6706528 · Received July 12, 2017

    Report

    Report Number
    2124215-2017-10319
    Event Type
    Injury
    Date Received
    July 12, 2017
    Date of Event
    December 8, 2016
    Report Date
    June 8, 2017
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073/S043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE TACHYCARDIA PORTION OF THIS LEAD REMAINS IN SERVICE. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASED PACING THRESHOLD MEASUREMENTS. A SURGICAL REVISION WAS PERFORMED AND THE PACE/SENSE PORTION OF THE LEAD WAS SURGICALLY ABANDONED, AND A NEW RV PACE/SENSE LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488902 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R 0185| 4086| E030