BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 3973806 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13851
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 10, 2014
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37751, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3998, LOT# V015166, IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD FALLEN 4 TIMES AND HER LEAD "FELT STRANGE WHEN HER STIMULATION TURNED ON." IT WAS NOTED THAT THE PATIENT WAS TOLD TO SEE THE HEALTHCARE PROFESSIONAL. IT WAS STATED THAT IT APPEARED TO HAVE OCCURRED THROUGH PRODUCT USE. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451349 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1