BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1991995 · Received February 4, 2011

    Report

    Report Number
    3004209178-2011-00899
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 19, 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
    TX
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED INTERMITTENT STIMULATION WHEN THE DEVICE WAS ON. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. SHE EXPERIENCED A LOSS OF THERAPEUTIC EFFECT IN THE LAST MONTH. SHE HAS BEEN RECHARGING; HOWEVER, THE STIMULATION WAS NOT WORKING. SHE WAS AT HOME IN FAIR CONDITION. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR IMPLANTED:| LEAD: MODEL 3887, LOT# J0227942V| EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC002480N| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD020630N| ACCESSORY: MODEL 37752, LOT# NKA017650N| EXPLANTED: