BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2211127 · Received August 8, 2011

    Report

    Report Number
    3004209178-2011-06129
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 13, 2011
    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCES OCCURRED. READINGS OF >10000 OHMS WERE REPORTED. ON PROGRAM A1>4000 OHMS (2-, 3-, 4+) AND ON PROGRAM A2 722 OHMS (10+, 11-, 12+). THE PT REPORTED A LOSS OF THERAPEUTIC EFFECT AND A BURNING SENSATION WHEN STIMULATION WAS TURNED ON. THE INS WAS CAUSING INCREASED BASELINE PAIN AND "IT IS ALL TWISTED AND MOVES AND HURTS REALLY BAD." NO KNOWN ACCIDENT OR INCIDENT WAS RELATED TO THIS COMPLAINT. THE LOCATION OF THE SYMPTOMS WAS THE LEFT AND RIGHT LEGS AND HIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB071841V| EXPLANTED:| ACCESSORY: MODEL 37752, LOT # NKA138263N| EXPLANTED:| LEAD: MODEL 3777, LOT# V401793023| PROGRAMMER: MODEL 37743, LOT# NKE144611N| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB071904V| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT# V401856001| IMPLANTED:| IMPLANTED: