BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2023441 · Received March 8, 2011

    Report

    Report Number
    3004209178-2011-01747
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED SHOCKING AT THE LEAD-EXTENSION CONNECTION LOCATION WHEN THE IMPLANTABLE NEUROSTIMULATOR WAS TURNED ON. IMPEDANCES WERE NORMAL. MOVEMENT AND PALPATION DID NOT CAUSE STIMULATION CHANGES. THERE WAS NO KNOWN INCIDENT OR ACCIDENT ASSOCIATED WITH THE ISSUE. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 38 YR IMPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE102708N| EXTENSION: MODEL 37081, LOT # NJB033586V| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT # V118916005| ACCESSORY: MODEL 37752, LOT # NKA113648N