BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1133155 · Received August 22, 2008

    Report

    Report Number
    3004209178-2008-05169
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 24, 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
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S STIMULATOR WAS SHOW THE EARLY REPLACEMENT INDICATOR (EIR) AT 45 DAYS. THE DEVICE WAS TYPICALLY SET AT 5.8-6.2 DURING THE DAY AND WAS TURNED DOWN OR OFF DURING THE NIGHT. THE PATIENT WAS ON HER FIRST VACATION IN 4 YEARS BECAUSE THE THERAPY REALLY WORKED FOR HER. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HEALTHCARE PROVIDER, 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 50 YR Required Intervention EXPLANTED:| PROGRAMMER: MODEL 37743| EXPLANTED:| LEAD: MODEL 3776| IMPLANTED:| LEAD: MODEL 3776| IMPLANTED: