BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISTA

    MDR report key: 1952356 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-24350
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    November 11, 2010
    Report Date
    January 13, 2011
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST QUALITY ASSURANCE LABORATORY THE DEVICE WAS RECEIVED WITH NO TELEMETRY THUS NO BATTERY STATUS COULD BE OBTAINED. DETAILED ANALYSIS NOTED THAT THE DEVICE PASSED ALL MANUAL ELECTRICAL MEASUREMENTS. THE DEVICE WAS UNABLE TO PACE WITH THE APPLICATION OF A MAGNET DUE TO THE DEPLETED CONDITION OF THE BATTERY AND INCREASED DEMANDS PLACED UPON IT WHEN ATTEMPTING TO PACE AT THE MAGNET RATE. BASED UPON THE LENGTH OF THE IMPLANT, LABORATORY ANALYSIS CONCLUDED THAT THE DEVICE HAS DEPLETED NORMALLY AND MEETS SPECIFICATION FOR NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    UPON ANALYSIS THIS EVENT WILL BE UDPATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT OF THIS PULSE GENERATOR (PG) THE BATTERY STATUS OF THE DEVICE WAS AT END OF LIFE (EOL) WITH A MAGNET RATE OF 83 BEATS PER MINUTE. AT THE PREVIOUS FOLLOW UP FOUR MONTHS PRIOR THE DEVICE INDICATED A MAGNET RATE OF 91 BEATS PER MINUTE. A DEVICE REPLACEMENT WAS SCHEDULED. THE CUSTOMER INQUIRED FOR TECHNICAL ADVICE WHEN IT CAME TO WHY THE DEVICE DECLARED EOL IN SUCH A SHORT TIME PERIOD. PREMATURE BATTERY DEPLETION WAS ALLEGED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. TECHNICAL SERVICES NOTED THAT IT WAS DIFFICULT TO ELABORATE ON THE POSSIBLE CAUSE FOR THIS RAPID DEPLETION AND RECOMMENDED EXPLANTING AND RETURNING THE DEVICE FOR ANALYSIS.

    Description of Event or Problem · 1

    NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISTA IMPLANTABLE PULSE GENERATOR NVZ HISTORICAL CPI ST. PAUL 0941

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 0941| 4271| 4161