BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2822624 · Received November 7, 2012

    Report

    Report Number
    3004209178-2012-09995
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Report Date
    October 10, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 748910 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION; PRODUCT ID, 7435 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID, 3888-56 LOT# V091860, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD; PRODUCT ID, 3888-56 LOT# V091860, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD NO STIMULATION SENSATION. THE PATIENT FELL 3 YEARS AGO ON BLACK ICE. SINCE THE FALL EVERY TIME SHE BENT OVER SHE FELT A SURGING SENSATION, LIKE ONE WOULD WHEN TURNING IT ON, IN BOTH OF HER LEGS. WHEN THE PATIENT WOULD TOUCH "A SPOT ON THE MIDDLE OF HER BACK," THE STIMULATION WOULD GO BACK TO NORMAL. THE "SPOT" WAS LOCATED WHERE THE "LUMP AND THE LEADS" WERE PLACED. THE PATIENT THEN WENT TO TURN ON STIMULATION AND "IT WOULDN'T WORK." THE PATIENT NO LONGER FELT STIMULATION. THE REPORTED ISSUE ALSO OCCURRED 3 YEARS PRIOR. THE PATIENT NEVER HAD THE DEVICE CHECKED AS SHE WAS OUT OF THE COUNTRY. THE PATIENT WAS LOOKING TO GET THE IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED. ADDITIONAL INFORMATION 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 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1