BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE, ULTRA

    MDR report key: 2050053 · Received March 31, 2011

    Report

    Report Number
    3004209178-2011-02465
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    January 10, 2011
    Report Date
    March 14, 2011
    Manufacturer
    MEDTRONIC 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

    THE PATIENT EXPERIENCED SEVERE SHOCKING SENSATION AT THE LEAD-EXTENSION CONNECTION WHILE CHANGING POSITIONS. THIS STARTED A FEW WEEKS AGO. PALPATING CAUSED STIMULATION CHANGES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR LEAD: MODEL 3998, LOT# V003655| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37711,| PROGRAMMER: MODEL 37743, LOT# NKE157881N| EXTENSION: MODEL 37081, LOT# NJB084962V| LEAD: MODEL 39565-30, LOT# V554320015| EXPLANTED:| IMPLANTED:| IMPLANTED:| LOT# NJH705845H| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 37081, LOT# NJB085117V| EXPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA146892N| EXPLANTED: