BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIGOR

    MDR report key: 2173639 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10942
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    November 17, 2003
    Report Date
    July 11, 2011
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR ANALYSIS AFTER 88 MONTHS OF IMPLANT. DETAILED ANALYSIS NOTED THE DEVICE HAD NO OUTPUT AND NO TELEMETRY. DUE TO THE LIMITED INFORMATION FROM THE FIELD AND THE DEPLETED CONDITION OF THE DEVICE, IT CAN NOT BE CONFIRMED EXACTLY WHEN THE DEVICE DECLARED THE ELECTIVE REPLACEMENT TIMEFRAME OR WHAT THE BATTERY VOLTAGE WAS AT THE TIME OF EXPLANT. IT IS CONFIRMED THAT ON THE DATE OF THE EXPLANT THE DEVICE HAD BEEN IMPLANTED LONGER THAN NOMINAL EXPECTED LONGEVITY. IN CONCLUSION, ANALYSIS CAN NOT BE PERFORMED DUE TO THE DEPLETED CONDITION OF THE DEVICE AND LIMITED INFORMATION FROM THE FIELD. THE ALLEGATION COULD NOT BE CONFIRMED THROUGH ANALYSIS.

    Additional Manufacturer Narrative · 1

    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 THIS PACEMAKER WAS EXPLANTED OVER SEVEN YEARS AGO. AT THAT TIME THERE WAS NO REPORTED ALLEGATIONS. HOWEVER, IT WAS NOW REPORTED THAT THE DEVICE WENT FROM THE ELECTIVE REPLACEMENT INDICATOR TO END OF LIFE VERY FAST. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIGOR IMPLANTABLE PULSE GENERATOR NVZ HISTORICAL CPI ST. PAUL 1230

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention 5524M| 1230| 5024M| 1274