BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 2100322 · Received May 16, 2011

    Report

    Report Number
    3004209178-2011-03563
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Report Date
    April 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A FALL, THE PATIENT HAD STIMULATION IN THE WRONG LOCATION. THE STIMULATION WAS IN THE SIDE OF HIS LEG, BUT AFTER THE FALL, IT WAS IN HIS BACK. AFTER THE FALL, THE PATIENT HAD A "PINCH" AT THE AREA OF THE LEAD, BUT THIS RESOLVED. THE STIMULATION SHIFTED WHEN HE CHANGED POSITIONS. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 STIM ACCESSORY: MODEL 3550-39, LOT# N273897| LEAD: MODEL 3778, LOT# V637765029| ACCESSORY: MODEL 37752, LOT# NKA148172N| EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE164203N| IMPLANTED:| LEAD: MODEL 3778, LOT# V637765028