BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3212604 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10063
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 24, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    --

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, THE RV IS-1 CHANNEL WAS SURGICALLY ABANDONED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT NOISE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD THAT RESULTED IN PACING TO BE INHIBITED WITH ASYSTOLE. OVERSENSING WAS ALSO PRESENT HOWEVER, THERE WAS NO INAPPROPRIATE THERAPY. PATIENT NOTED BEING IN ATRIAL FIBRILLATION (AF) AND IS ESSENTIALLY PACER DEPENDENT. A VENOGRAM WAS GOING TO BE PERFORMED. TACHY THERAPY WAS TURNED OFF UNTIL LEAD REVISION PERFORMED. PATIENT HAS LIFE VEST. A REQUEST FOR LEAD STATUS HAS BEEN SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314106 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R 4512| 4469| H215| N118| H135| 0158