BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1201519 · Received October 17, 2008

    Report

    Report Number
    3004209178-2008-06635
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 19, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT LOST STIMULATION, AND WAS UNABLE TO TURN IT BACK ON. TELEMETRY REVEALED AN END OF SERVICE MESSAGE; NO EARLY REPLACEMENT INDICATOR MESSAGE HAD BEEN RECEIVED. BASED ON THE PATIENT'S HIGH ENERGY PROGRAMS, AND REPORT THAT THE PATIENT DID NOT USE THE DEVICE FULL-TIME, LONGEVITY WAS ESTIMATED AT 3-4 MONTHS. THE PATIENT STIMULATOR WAS REPLACED WITH A RECHARGEABLE MODEL. NO PATIENT OUTCOME WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention EXPLANTED:| PROGRAMMER MODEL 37743 LOT# NKE112061N| LEAD MODEL 39565 LOT# N144817006| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION MODEL 37081 LOT# NJB036525V| EXTENSION MODEL 37081 LOT# NJB024725V| EXPLANTED:| EXPLANTED: