BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1961118 · Received January 12, 2011

    Report

    Report Number
    3004209178-2011-00292
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    November 1, 2010
    Report Date
    November 30, 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
    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 WAS SEEN BY THE COMPANY REPRESENTATIVE FOR REPROGRAMMING AT WHICH TIME SHE HAD INTENSE RIB AND BELLY PAIN. WHEN THE LEAD WAS MAPPED OUT, THE UPPER SEGMENT ONLY YIELDED RIB AND ABDOMINAL STIMULATION. THE BOTTOM OF THE LEAD ARRAY WAS ABLE TO CAPTURE BACK AND PARTIALLY DOWN LOWER LEFT EXTREMITY TO KNEE AREA. EIGHT DAYS LATER, THE PHYSICIAN REVISED THE LEAD. IT HAD BEEN NOTED THAT THE LEAD HAD MIGRATED CEPHALAD COMPARED TO THE ORIGINAL IMPLANT LOCATION. IT HAD THEN MIGRATED EVEN FURTHER WITH THE PT THEN LOSING ALL STIMULATION SENSATION. THE LEAD HAD BEEN ANCHORED AND HAD A STRAIN RELIEF LOOP WRAPPED AROUND THE INCISION OVERLYING THE VERTEBRAL SEGMENTS. THE PHYSICIAN DISSECTED AWAY THE LAMINA AND PULLED THE LEAD DOWN. THE PT WAS NOT ABLE TO KEEP THE COVERAGE ON THE BACK AND GOT COVERAGE AT THE PRIMARY TARGET OF THE LEG AND FOOT. THE SURGEON RE-ANCHORED THE LEAD. THE PT RECOVERED WITHOUT SEQUELAE. POST-OPERATIVELY, THE PT WAS HAPPY WITH THE STIMULATION. IT WAS ALSO NOTED THAT THE PT'S PROGRAMMER HAD QUIT COMMUNICATING WITH THE NEUROSTIMULATOR, EVEN WITH A CHANGE OF BATTERIES. ANOTHER PROGRAMMER WAS ABLE TO COMMUNICATE WITH THE DEVICE WITH NO PROBLEMS AND A NEW PROGRAMMER WAS ISSUED TO THE PT. SUBSEQUENT REPROGRAMMING IMPROVED STIMULATION COVERAGE INTO THE PT'S FOOT AND INCREASED STIMULATION TO THE HIPS BUT NOT TO THE BACK AREA.

    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 38 YR Required Intervention EXPLANTED:| PROGRAMMER: MODEL 37743, LOT #: NKE139245N| LEAD: MODEL 39286-65, LOT #: V346394034| IMPLANTED: