BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 2061853 · Received April 4, 2011

    Report

    Report Number
    3004209178-2011-02545
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    November 1, 2010
    Report Date
    March 16, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A SHOCKING SENSATION FOLLOWING A FALL. THE PT FELT THE SHOCKING SENSATION AT THE LEAD LOCATION WHEN DOING "CERTAIN" MOVEMENTS. THE PT WAS CHARGING MORE THAN HE EXPECTED AS HE CHARGED FOR ABOUT 3 HRS ONCE A WEEK. THE PT USED TO ONLY CHARGE EVERY 3-4 WEEKS, AND THE CURRENT STIMULATOR SETTINGS WERE LOWER THAN BEFORE. THE RPTR NOTED THE PT WAS CONFUSING THE COUPLING BARS WITH THE STIMULATOR CHARGE LEVEL. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO 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 40 YR IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC002877N| PROGRAMMER: MODEL 37742, LOT# NJD024197N| EXTENSION: MODEL 37083, LOT# NKC002071N| LEAD: MODEL 3487A, LOT# J0343673V