BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2060079 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-06319
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVISION PROCEDURE WAS PERFORMED. THE RV AND RA LEADS WERE SUCCESSFULLY REPOSITIONED. THE LV PACING LEAD WAS UNSUCCESSFULLY ATTEMPTED FOR RE-POSITIONING AND A SECOND LV WAS ALSO UNSUCCESSFULLY ATTEMPTED. THE IMPLANTING PHYSICIAN COULD NOT FIND A VEIN THAT WOULD CAPTURE. THE DEVICE LV PORT WAS PLUGGED. NO FURTHER ISSUES HAVE BEEN REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS EVENT WILL BE REOPENED SHOULD FURTHER INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (BSC) RECEIVED INFORMATION THAT THE PATIENT WITH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAS TWIDDLER'S SYNDROME AND AS A RESULT, HAD DISLODGED THEIR LEADS (RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD, NON-BSC RIGHT ATRIAL (RA) PACING LEAD, AND LEFT VENTRICULAR (LV) PACING LEAD).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention N119| MISMATCH| 4542| 0185