BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IITREL 3

    MDR report key: 1901969 · Received November 12, 2010

    Report

    Report Number
    6000032-2010-09437
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    March 17, 2010
    Report Date
    October 29, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., MED REL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO ADJUST THE STIMULATION. HE HAD A SPINAL CORD STIMULATOR THAT WAS INSTALLED IN (B)(6) 2005. HE HAD IT ON CONTINUOUSLY AND USED THE PROGRAMMER TO CHANGE THE LEVEL OF STIMULATION WHEN HE SAT OR STOOD. TWO DAYS PRIOR WHEN HE WENT TO USE THE PATIENT PROGRAMMER ALL THE LIGHTS CAME ON AND IT WOULD NOT WORK. HE CHANGED THE BATTERY AND IT STILL DIDN'T WORK. HE LEFT THE BATTERY OUT OF THE DEVICE FOR A WHILE AND IT DID START WORKING AGAIN. THE SAME THING THEN CONTINUED TO HAPPEN EACH TIME HE USED IT. PATIENT REPORTED (B)(6) 2010, HE HAD A LEAD BREAK AT IMPLANTABLE NEUROSTIMULATOR (INS) CONNECTOR SITE, BUT HCP WAS ABLE TO PROGRAM TO ALLOW RELIEF UNTIL INS BATTERY WAS DEPLETED. PT'S NEW INS WAS WORKING WELL TO ALLOW PAIN RELIEF AND MEDICATION REDUCTION. HE JUST HAD TO HAVE AN UPDATE TO MY SPINAL CORD STIMULATOR. HIS OLD BATTERY WENT LOW AND THE LIGHT WAS BLINKING ON THE PROGRAMMER, AND HIS STIMULATOR WAS ONLY WORKING ON ONE ELECTRODE. WHEN THE DOCTOR OPENED HIM UP HE FOUND THAT THE WIRE WAS BROKEN ON BOTH SIDES OF THE SPLICE PLUG, LEADING TO THE BATTERY, AND TO THE ELECTRODE. SO EVERYTHING HAD TO BE REPLACED. IT HAD BEEN LIKE THIS FOR AT LEAST 3 YEARS AND NO ONE WAS ABLE TO FIGURE THIS OUT. AT LEAST HE HAD ONE WORKING ELECTRODE. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IITREL 3 LGW MDT PUERTO RICO OPERATIONS CO., MED REL 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU042178V| LEAD: MODEL 3587A, LOT# N0019358| EXPLANTED:| PROGRAMMER: MODEL 7434A, LOT# NGL015459P| EXPLANTED:| IMPLANTED: