BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 3234061 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11976
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 28, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3487A, LOT# J0008020V, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: LEAD; PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE: EXTENSION; PRODUCT ID 7435, SERIAL# (B)(4): PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND IT WAS UNKNOWN WHEN THIS BEGAN. IT WAS REPORTED THAT THE IMPEDANCES WERE GREATER THAT 4,000 OHMS ON ALL BIPOLAR PAIRS. IT WAS REPORTED THAT THE PATIENT "BARELY FELT ANYTHING" WHEN THE AMPLITUDE WAS TURNED UP TO 10.5V AND ALL 4 ELECTRODES WERE ACTIVE. IT WAS NOTED THAT THE REPORTER THOUGHT THE CURRENT CONDITION OF THE BATTERY WAS "STILL GOOD." ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S HEALTH CARE PROVIDER (HCP) WAS MADE AWARE OF THE PATIENT'S CURRENT CONDITION AND THE HCP PLANNED TO FOLLOW UP WITH THE PATIENT IN THE FUTURE. IT WAS NOTED THAT THE PATIENT WAS NOT INTERESTED IN HAVING THE SYSTEM REVISED OR REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334053 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1