BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1834579 · Received September 9, 2010

    Report

    Report Number
    3004209178-2010-06912
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 24, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RECHARGER WAS RETURNED FOR ANALYSIS; ANALYSIS RESULT: "COMPLAINT UNVERIFIED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STIMULATION HAD TURNED OFF TWICE ON ITS OWN. THE PATIENT PROGRAMMER VERIFIED THAT THE STIMULATION WAS OFF UPON SYNCHRONIZATION. WHEN THE STIMULATION WAS AT APPROXIMATELY 3/4 FULL, THE STIMULATION TURNED OFF UNTIL THREE HOURS LATER. THIS HAD OCCURRED FOUR TIMES IN THE PAST THREE MONTHS. PATIENT WAS ALSO CHARGING MORE THAN EXPECTED; NOW EVERY FOUR DAYS PREVIOUSLY EVERY 8-10 DAYS. PATIENT REPORTED NO FAILS OR TRAUMA AND RECEIVED GOOD THERAPY WHEN STIMULATION WAS ON. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 44 YR IMPLANTED:| IMPLANTED:| LEAD: MODEL 3887, LOT# J0349509V| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD017160N| LEAD: MODEL 3887, LOT# J0527208V| EXTENSION: MODEL 37083, LOT# NKC002981N| IMPLANTABLE NEURO STIMULATOR: MODEL 7427| IMPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7427| LOT# NFE142684H| IMPLANTED:| LEAD: MODEL 3887, LOT# J0537488V| EXTENSION: MODEL 7489, LOT# NHU032603V| IMPLANTED:| LOT# NFE142684H| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA013791N1| EXTENSION: MODEL 37083, LOT# NKC002980N| LEAD: MODEL 3887, LOT# J0349466V| PROGRAMMER: MODEL 7435, LOT# NFT036166P