BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1812483 · Received August 16, 2010

    Report

    Report Number
    3004209178-2010-06157
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 19, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BURN HAD OCCURRED DURING A RECHARGING SESSION OF THE PATIENT'S DEVICE. THE PATIENT WAS CHARGING THE BATTERY, AND FELL ASLEEP FOR 5 HOURS IN RECLINER. AFTER AWAKING, THE PATIENT NOTICED THAT THE RECHARGER HAD SLIPPED TOWARD BUTTOCK AREA. THE WOUND WAS LOCATED A FEW INCHES LATERAL OF THE IMPLANTED NEUROSTIMULATOR DEVICE, IN THE BUTTOCK AREA. THE DEVICE HAD BEEN IMPLANTED SPECIFICALLY IN THE PATIENT'S RIGHT GLUTEUS. IT WAS ALSO NOTED THAT THE PATIENT WAS A PARAPLEGIC AND DOES NOT HAVE SENSATION IN THE AFFECTED AREA, NOR AT THE DEVICE POCKET SITE. THE AREA OF THE WOUND BECAME BLACK AND NECROTIC. THE DEVICE WAS EXPLANTED AT THE REQUEST OF THE PATIENT. THE PATIENT'S STATUS WAS THAT HE HAD RECOVERED WITH SEQUELA. ADDITIONAL INFORMATION 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 51 YR Required Intervention IMPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA028409N| PROGRAMMER: MODEL 37742, LOT# NJD043066N| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT# V023003037| LEAD: MODEL 3777, LOT# V023307013| EXPLANTED:| IMPLANTED: