BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1872576 · Received October 12, 2010

    Report

    Report Number
    3004209178-2010-07847
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 14, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A BAD FALL AND THAT THREE OF HER LEADS WERE NOT WORKING SINCE THEN. SHE STATED THAT WHEN SHE TURNED ONE LEAD UP THAT SHE EXPERIENCED A BAD CRAMP/MUSCLE TIGHTENING. PT WAS NOT GETTING STIMULATION IN ALL THE PLACES SHE USED TO. 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 58 YR ACCESSORY: MODEL 37752, LOT# NKA037921N| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3487A, LOT# V122093| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB013842N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB013828N| LEAD: MODEL 3888, LOT# V134083| EXPLANTED:| LEAD: MODEL 3487A, LOT# V122093| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD061591N| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT# V129468