BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 2911866 · Received January 11, 2013

    Report

    Report Number
    2124215-2013-00385
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    March 1, 2012
    Report Date
    December 7, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURN OF THIS PRODUCT IS NOT EXPECTED AT THIS TIME. 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 ROUTINE REPLACEMENT OF THIS PACEMAKER WITH ANOTHER MANUFACTURER'S DEVICE, ATTEMPTS WERE MADE TO LOOSEN THE VENTRICULAR SETSCREW WITH SEVERAL OTHER MANUFACTURER'S TORQUE WRENCHES WITHOUT SUCCESS. SUBSEQUENTLY, THE INSULATION ON THIS RIGHT VENTRICULAR (RV) LEAD BECAME DAMAGED AND LOSS OF CAPTURE (LOC) WAS OBSERVED. THE DEVICE WAS THEN PROGRAMMED TO UNIPOLAR AND CAPTURE WAS RESTORED. THE PHYSICIAN FELT THAT THE SETSCREW WAS STRIPPED, SO THE BACK OF THE DEVICE HEADER WAS CUT OFF TO ATTEMPT TO LOOSEN THE SETSCREW AND REMOVE THE RV LEAD, HOWEVER, WAS ALSO UNSUCCESSFUL. FINALLY, AN ADDITIONAL MANUFACTURER'S TORQUE WRENCH WAS USED AND THE SETSCREW WAS SUCCESSFULLY LOOSENED. THE RV LEAD WAS REMOVED FROM THE DEVICE HEADER AND SURGICALLY ABANDONED. A NEW DEVICE AND LEAD WERE SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19064 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR MISMATCH| 4086| 1284| 4087