BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2219989 · Received August 9, 2011

    Report

    Report Number
    3004209178-2011-06178
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 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

    IT WAS REPORTED THAT THE PT EXPERIENCED A SHOCKING OR JOLTING SENSATION AT THE SITE OF THE NEUROSTIMULATOR WHILE STANDING TAKING A SHOWER. THERE HAD BEEN NO FALL OR TRAUMA PRIOR TO THE EVENT. IMPEDANCES WERE WITHIN NORMAL LIMITS. PRESSING ON THE NEUROSTIMULATOR REPRODUCED THE SHOCKING SENSATION. NO MALFUNCTIONS WERE IDENTIFIED. NO INTERVENTIONS HAD TAKEN PLACE OR WERE PLANNED. THE PT'S OUTCOME WAS UNDETERMINED; THE PT WAS WAITING "TO SEE HOW THINGS GO."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE162213N| LEAD: MODEL 3778, LOT# V264440011| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA130508N| LEAD: MODEL 3778, LOT# V416780025| EXPLANTED: