BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1861171 · Received October 4, 2010

    Report

    Report Number
    3004209178-2010-07591
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 23, 2001
    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). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STARTING "ABOUT TWO WEEKS" PRIOR, THE PT FELT STIMULATION WHERE THE WIRES WERE LOCATED EVEN WHEN THE STIMULATION WAS TURNED OFF. THE PT ALSO REPORTED FEELING SHARP PAIN AT THE IMPLANTABLE NEURO STIMULATOR (INS) SITE, OVER HIS LEFT HIP BONE, FOR "ABOUT ONE MONTH" REGARDLESS OF WHETHER THE STIMULATION WAS ON OR OFF. TROUBLESHOOTING INDICATED THE RECHARGER WAS WORKING, INS AT 50%. THE PT WAS SCHEDULED TO MEET WITH THE HEALTH CARE PROVIDER (HCP) IN OCTOBER. THE PT WAS REDIRECTED TO THE HCP. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC003693N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC003597N| EXPLANTED:| LEAD: MODEL 3998, LOT# V003187| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD039794N| IMPLANTED:| IMPLANTED: