BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1953853 · Received January 4, 2011

    Report

    Report Number
    3004209178-2011-00054
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 12, 2010
    Report Date
    December 20, 2010
    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
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    RECEIVED INFO THAT THERE WAS BREAKAGE OR DISLODGEMENT OF THE LEAD OR EXTENSION. THE SYS WAS EXPLANTED. DEVICES HAS BEEN RETURNED TO MFR FOR ANALYSIS. PT WAS REPORTED AS SUFFERING NO INJURY AND RECOVERED WITHOUT SEQUELA. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, A F/U REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention EXPLANTED:| STIM ACCESSORY: MODEL 3550-39, LOT# UNK| IMPLANTED:| STIM ACCESSORY: MODEL 3550-39, LOT# UNK| EXPLANTED:| LEAD: MODEL 3778, LOT# V016824| LEAD: MODEL 3778, LOT# V016824| ACCESSORY: MODEL 37752, LOT# NKA025162N| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD037335N| IMPLANTED: