BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2344037 · Received November 21, 2011

    Report

    Report Number
    3004209178-2011-09338
    Event Type
    Malfunction
    Date Received
    November 21, 2011
    Date of Event
    October 23, 2011
    Report Date
    October 25, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD: MODEL 3778, LOT# V098328011, IMPLANTED: 2008 (B)64), EXPLANTED: NA. NEURO ADAPTOR: MODEL 3550, LOT# N143115, IMPLANTED: 2008 (B)(6), EXPLANTED: NA. PROGRAMMER: MODEL 37743, LOT# NKE104083N. RECHARGER: MODEL 37752, LOT# NKA112650N.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A "HORRIBLE" SHOCKING SENSATION AROUND THE LOCATION OF THE LEAD, AFTER BENDING OVER TO PICK UP A CHILD. THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR WAS REPORTED TO BE "DEAD" AT THE TIME THE SHOCKING SENSATION WAS FELT. THE PATIENT HAD X-RAYS PERFORMED IN THE EMERGENCY ROOM (ER). HOWEVER, IT WAS NOT KNOWN WHETHER ANYTHING HAD MOVED. NO INFORMATION WAS REPORTED RELATED TO THE PATIENT'S OUTCOME. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00027 YR