BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1150246 · Received September 3, 2008

    Report

    Report Number
    6000032-2008-05425
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    May 1, 2008
    Report Date
    August 6, 2008
    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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT EXPERIENCED A SHOCKING AND BURNING SENSATION DOWN HER LEFT LEG IN 2008. SHE STOPPED USING HER IMPLANTABLE NEUROSTIMULATOR. THE PT TRIED ON DIFFERENT OCCASIONS TO TURN DEVICE BACK ON WITH THE SAME EFFECTS. THE PT WAS SEEN IN CLINIC 3 MONTHS AFTER HER SYMPTOMS BEGAN AND WAS INFORMED THAT HER 'CONDENSER WASN'T WORKING'; X-RAYS SHOWED AN 8 ELECTRODE LEAD LOCATED RELATIVELY MIDLINE AT THE TOP OF T8 AND A 4 ELECTRODE SURGICAL LEAD THAT WAS LEFT OVER AND DISCONNECTED FROM THE PREVIOUS SYSTEM AT T10/11 (APPROX TWO MONTHS LATER). A WEEK LATER, THE PT WAS AGAIN SEEN IN CLINIC. HER CHIEF COMPLAINT WAS OF PAIN IN THE MIDDLE OF HER BACK, OVER THE INCISION WHERE THE LEAD WAS PLACED. SHE HADN'T FALLEN. THE IMPLANTABLE NEUROSTIMULATOR WAS TURNED ON. THE PT WAS GETTING GOOD STIMULATION IN BOTH LEGS FOR ABOUT A MINUTE BEFORE SHE STARTED WRITHING IN PAIN AND STATING "MY BACK HURTS". THE DEVICE WAS QUICKLY TURNED OFF AND REPROGRAMMED USING FEWER ELECTRODES. AFTER REPROGRAMMING THE PT STATED THAT HER MID BACK HURT UPON STARTING STIMULATION. THE DEVICE WAS QUICKLY TURNED OFF AGAIN. NO FURTHER REPROGRAMMING ATTEMPTS WERE TRIED. BOTH THE BATTERY AND ELECTRODE IMPEDANCES WERE FINE. THE HCP PLANNED TO REPLACE THE LEAD AND PULSE GENERATOR. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MDT PUERTO RICO OPERATIONS CO, MED REL 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| EXTENSION MODEL 7471 LOT# NHJ003221N IMPLANTED:| EXPLANTED:| LEAD MODEL 3898 LOT# LB2395 IMPLANTED:| LEAD MODEL UNK IMPLANTED:| EXPLANTED: