BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2013503 · Received February 3, 2011

    Report

    Report Number
    3004209178-2011-00856
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 19, 2010
    Report Date
    January 19, 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 FELT STIMULATION IN THE WRONG LOCATION AND EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IMPLANTABLE NEUROSTIMULATOR INTERROGATION REVEALED HIGH OUT-OF-RANGE IMPEDANCES. THE NEUROSTIMULATOR ITSELF SEEMED TO BE WORKING FINE. THE PT WAS DEFIBRILLATED IN THE HOSPITAL. IT IS UNCLEAR IF THE NEUROSTIMULATION PROBLEMS OCCURRED BEFORE OR AFTER DEFIBRILLATION. 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 RECHARGEABLE NEUROSTIMULATOR LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR EXPLANTED:| LEAD: MODEL 3487A, LOT# V375102| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB002906V| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE143975N| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA144386N| LEAD: MODEL 3487A, LOT# V373716| LEAD: MODEL 3778, LOT# V416780028| EXPLANTED:| IMPLANTED:| IMPLANTED: