BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1230004 · Received November 12, 2008

    Report

    Report Number
    3004209178-2008-07401
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 15, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    Description of Event or Problem · 1

    TO ACHIEVE THERAPEUTIC BENEFIT, THE PATIENT HAD TO INCREASE THE NEUROSTIMULATOR AMPLITUDE TO 4.0 VOLTS. HE EXPERIENCED A SHOCKING OR JOLTING SENSATION AT THE NEUROSTIMULATOR LOCATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 PROGRAMMER: MODEL 37743| RECHARGER: MODEL 37752| EXTENSION: MODEL 37081| LEAD: MODEL 39565| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081| IMPLANTED: