BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2589180 · Received May 25, 2012

    Report

    Report Number
    3004209178-2012-03738
    Event Type
    Malfunction
    Date Received
    May 25, 2012
    Report Date
    April 30, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EXTENSION/ADAPTOR MODEL 7496-51, SERIAL# (B)(4), IMPLANTED: 1994-(B)(6), EXPLANTED: NA, PROGRAMMER MODEL 7435, SERIAL# (B)(4), LEAD MODEL 3982, SERIAL# (B)(4), IMPLANTED: 1994-(B)(6), EXPLANTED: NA, PLUG/CAP ACCESSORY MODEL 3550-09, LOT# N112965, IMPLANTED: 2008-(B)(6), EXPLANTED: NA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST HIS STIMULATION OF THEIR IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM AFTER BEING IN A WALMART. THE PATIENT STATED THAT HE WAS NOT SURE IF THIS VISIT DID SOMETHING TO HIS DEVICE OR NOT AND NOW WHEN HE TRIED TO ADJUST THE STIMULATION (INCREASE OR DECREASE) HE WOULD GET 3 "BEEPS" FROM THE PROGRAMMER. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME 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