BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2073596 · Received April 26, 2011

    Report

    Report Number
    3004209178-2011-03100
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 7, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED STIMULATION IN THE WRONG LOCATION WHICH RESULTED IN NOT USING HIS DEVICE FOR THE PAST FEW MONTHS. HE UNDERWENT A LEAD REVISION. FOLLOWING THE REVISION, THE INS WAS FOUND TO BE OVERDISCHARGED. A POWER ON RESET (POR) OCCURRED AND THERE WERE TELEMETRY ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention LEAD: MODEL 3778, LOT# V557253039| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V571324025| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE158901N| ACCESSORY: MODEL 37752, LOT# NKA147311N| IMPLANTED: