BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1981614 · Received January 31, 2011

    Report

    Report Number
    3004209178-2011-00731
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Report Date
    January 17, 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
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED NO STIMULATION EXCEPT WHEN SHE CHANGED BODY POSITION FOLLOWING A FALL. THE PT FELL ON HER HIP. NO TROUBLESHOOTING, INTERVENTION, OR OUTCOME WAS REPORTED. ADD'L INFO 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 ADVANCED RECHARGEABLE LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD030111N| IMPLANTED:| LEAD: MODEL 3777, LOT# V013670