BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1885283 · Received October 25, 2010

    Report

    Report Number
    3004209178-2010-08412
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 8, 2010
    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
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S SKIN OVER THE IMPLANTABLE NEURO STIMULATOR SITE ITCHED "LIKE CRAZY." WHEN THE STIMULATION WAS ON, THE PATIENT WOULD FALL BACK DOWN WHEN HE TRIED TO STAND UP BECAUSE THE STIMULATION "KILLS" THE NERVES IN HIS LEGS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION 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 53 YR PROGRAMMER: MODEL #37743, LOT #NKE121859N| EXPLANTED:| LEAD: MODEL #39565-30, LOT #N179324001| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL #37081, LOT #NJB048316V| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL #37752, LOT #NKA123811N| EXTENSION: MODEL #37081, LOT #NJB049561V| EXPLANTED:| IMPLANTED:| IMPLANTED: