BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2102686 · Received May 19, 2011

    Report

    Report Number
    3004209178-2011-03650
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 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
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS SHOWED THAT THE ANTENNA JACK ON THE PT PROGRAMMER WAS BROKEN. IT WAS REPLACED.

    Description of Event or Problem · 1

    THE PT "RAN INTO A WALL" AND THEN EXPERIENCED A SHOCKING SENSATION WHEN SITTING OR LYING DOWN. THE PT HAD TO TURN UP THE VOLTAGE OF THE DEVICE TO COVER THIS PAIN AND THEN FELT SHOCKING. IT ALSO REPORTED THAT A BROKEN ANTENNA JACK WAS SEEN ON HIS PT PROGRAMMER. THIS PREVENTED HIM FROM BEING ABLE TO ADJUST THE STIMULATION. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT 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 49 YR PROGRAMMER: MODEL 37743, LOT# NKE135661N| LEAD: MODEL 3778, LOT# V339175021| IMPLANTED:| EXPLANTED: