BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA

    MDR report key: 3052644 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04590
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WOULD BE UPDATED.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE CHANGE OUT PROCEDURE FOR NORMAL BATTERY DEPLETION, THE RIGHT ATRIAL (RA) LEAD BECAME STUCK IN THE HEADER OF THE DEVICE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND IT WAS CONFIRMED THAT BOTH SET SCREWS WERE FULLY DISENGAGED. THE LEAD WAS DAMAGED DURING FURTHER ATTEMPTS TO REMOVE IT FROM THE DEVICE. SUBSEQUENTLY THE RA LEAD WAS SURGICALLY ABANDONED AND THE DEVICE EXPLANTED. A NEW DEVICE AND RA LEAD WERE SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PRIOR TO THE DEVICE CHANGE OUT PROCEDURE, THEY WERE UNABLE TO INTERROGATE THE DEVICE. THEY WERE ABLE TO CONFIRM THE DEVICE HAD REACHED ITS END OF LIFE (EOL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154514 DELTA IMPLANTABLE PULSE GENERATOR NVZ HISTORICAL CPI ST. PAUL 0926

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR 4266| 4469| 0926| 4260| S602