BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1080749 · Received July 23, 2008

    Report

    Report Number
    3004209178-2008-04275
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 5, 2004
    Report Date
    June 26, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED THAT SHE STARTED NOTICING A SHOCKING/PINCHING FEELING THAT WAS INTERMITTENT IN VARIOUS PLACES (KNEE, HIP, POCKET SITE) AND A BURNING SENSATION AT THE LEAD SITE. THE PT WAS IN A LOT OF PAIN. IMPEDANCES WERE CHECKED AND FOUND TO BE HIGH; THE EXACT READING WAS NOT PROVIDED. AN EXPLORATORY SURGERY WAS DONE IN 2004, AND A COUPLE OF DAYS AFTERWARDS, THE SHOCKING RETURNED. THE PT HAD NOT EXPERIENCED A FALL OR TRAUMA. THE PT FELT THE SYMPTOMS WITH THE STIMULATION ON OR OFF. THE HEALTH CARE PROFESSIONAL ADVISED THE PT TO TURN THE STIMULATOR OFF AND DOUBLE UP ON HER MEDICATIONS. AT ABOUT APPROXIMATELY 27 DAYS LATER, THE HCP DID AN UNSPECIFIED REVISION OF THE EPIDURAL ELECTRODE AND THE NEUROSTIMULATOR. THE PT WAS SEEN AT A POST-OPERATIVE VISIT AT ABOUT 9 DAYS LATER, AND WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 7427V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROGRAMMER MODEL 7438| IMPLANTED| EXPLANTED| IMPLANTED| EXTENSION MODEL 7489 LOT# NHU047904V| EXPLANTED| IMPLANTED| EXTENSION MODEL 7489 LOT# NHU047905V| EXPLANTED| LEAD MODEL 3998 LOT# J0406547V