BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2011-04960

    MDR report key: 2051907 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-04960
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 23, 2011
    Report Date
    June 22, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, NO FURTHER DETAILS HAVE BEEN PROVIDED. IF NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE IMPLANTED LESS THAN 12 MONTHS, WAS EXHIBITING LESS THAN ONE YEAR OF REMAINING SERVICE LIFE. AN INQUIRY WAS SENT FOR TECHNICAL REVIEW. ADDITIONALLY, A DEVICE ALERT NOTIFICATION TO CHECK THE ASSOCIATED ATRIAL LEAD HAD BEEN OBSERVED. NO INFORMATION PROVIDED ON THE SPECIFICS OF THE FAULT CODE OR THE ATRIAL LEAD MODEL SERIAL NUMBER. NO ADVERSE PATIENT EFFECTS WERE REPORTED AND TO DATE THE DEVICE AND LEAD REMAIN IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    SUBSEQUENTLY, SURGICAL INTERVENTION TO EXPLANT THE DEVICE WAS PERFORMED AT WHICH TIME THIS LEAD WAS TESTED AND CONFIRMED TO BE FUNCTIONING APPROPRIATELY. THE LEAD REMAINED IMPLANTED AND IN SERVICE WITH THE NEW DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NVN GUIDANT PUERTO RICO BV BRADY LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1