BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1980982 · Received February 8, 2011

    Report

    Report Number
    2124215-2011-02161
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN ELECTED TO REMOVE THIS RV LEAD FROM SERVICE ONE DAY POST-IMPLANT. THE REST OF THE SYSTEM WAS ALSO REMOVED AS A RESULT, FOR IN ATTEMPTING TO REMOVE THIS RV LEAD, BOTH THE NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD AND THE LEFT VENTRICULAR (LV) LEADS BECAME DISLODGED. IT WAS OBSERVED THAT THE LV LEAD THEN BEGAN TO UNRAVEL, LEADING TO COMPLICATION WITH REMOVING THIS LV LEAD, RESULTING IN RESULT DISSECTION AND OCCLUSION OF THE SUPERIOR VENA CAVA. THE LV LEAD WAS ULTIMATELY REMOVED IN PIECES. THE RA LEAD WAS REMOVED WITHOUT ISSUE. THE ASSOCIATED CRT-D WAS ALSO REMOVED WITHOUT ISSUE, BEYOND THE ALLEGATION OF RV UNDERSENSING AND ATTEMPTED RE-PROGRAMMING. THE PATIENT REMAINED HOSPITALIZED FOR MONITORING, AND WAS NOTED AS STABLE. MOST RECENTLY, THE PATIENT HAD NO SYSTEM IMPLANTED. A LEFT-SIDED IMPLANT WAS BEING EVALUATED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, INVESTIGATION IS CONSIDERED COMPLETE. THIS REPORT WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD WAS REMOVED FROM SERVICE ALONG WITH THE REST OF THE PATIENT'S DEVICE SYSTEM ONE DAY POST-IMPLANT. ONLY TWO OF THE PRODUCTS IN THE DEVICE SYSTEM WERE INVOLVED FOR POTENTIALLY LIFE THREATENING OCCURRENCE, AS FOLLOWS: DURING IMPLANT OF THE ACUTE DEVICE SYSTEM, THIS RV LEAD IN ASSOCIATION WITH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DID EXHIBIT RV UNDERSENSING. THIS UNDERSENSING WAS THE RESULT OF ATRIAL OVERSENSING OF THE RV WHICH IN TURN LED TO BLANKING OF THE RV. THE UNDERSENSING DID DELAY THERAPY FOR AN UNKNOWN DURATION. THE PHYSICIAN ATTEMPTED TO CORRECT THIS ISSUE WITH RE-PROGRAMMING DURING THE SAME PROCEDURE. IT REMAINS UNCLEAR WHETHER THERE WAS MORE UNDERSENSING POST-ADJUSTMENT OF THE BLANKING PERIOD. THE PATIENT WAS NOTED TO HAVE A HISTORY OF HIGH DEFIBRILLATION THRESHOLD (DFTS) TESTING MEASUREMENTS ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR 4518| 5076| N118| H219| 0184