BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911383 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16673
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS CUT AND SURGICALLY ABANDONED. 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 DURING THE ROUTINE DEVICE CHANGE OUT FOR NORMAL BATTERY DEPLETION, THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD WOULD NOT RELEASE FROM THE HEADER. THE PHYSICIAN ELECTED TO CUT AND ABANDONED THE LEADS. A SUCCESSFUL IMPLANT OF A NEW RIGHT VENTRICULAR (RV) LEAD. THE PHYSICIAN ELECTED NOT TO IMPLANT AN RIGHT ATRIAL (RA) LEAD BECAUSE OF THE PATIENT'S CHRONIC ATRIAL FIBRILLATION (AF). THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16588 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR 4543| 4538| H177| 0185| N161| 4087