BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2402809 · Received January 6, 2012

    Report

    Report Number
    3004209178-2012-00132
    Event Type
    Injury
    Date Received
    January 6, 2012
    Report Date
    December 19, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXTENSION: MODEL 748925, (B)(4), IMPLANTED: 2008 (B)(6), EXPLANTED: NA, EXTENSION: MODEL 748925, (B)(4), IMPLANTED: 2008 (B)(6), EXPLANTED: NA, LEAD: MODEL 3487A-33, LOT# V101633, IMPLANTED: 2008 (B)(6), EXPLANTED: NA, LEAD: MODEL 3487A-33, LOT# V072248, IMPLANTED: 2008 (B)(6), EXPLANTED: NA, PROGRAMMER: MODEL 7435, (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DEPLETION OF THE NEUROSTIMULATOR WAS CONSIDERED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED NO STIMULATION SENSATION AND WAS IN EXTREME PAIN AFTER FALLING ON SOME ICE AND TWISTING HER BACK TWO WEEKS AGO. SINCE THEN SHE HAD TRIED TO INCREASE STIMULATION AND CHANGE THE SETTINGS, BUT STILL DID NOT FEEL STIMULATION. THE BATTERY SEEMED TO BE ON AND THE PACK SEEMED TO BE WORKING, BUT THE PATIENT THOUGHT THE LEADS WERE NOT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT INTERROGATION OF THE IMPLANTABLE NEUROSTIMULATOR INDICATED A LOW BATTERY. THE PATIENT HAD HER BATTERY SUCCESSFULLY REPLACED ON (B)(6) 2011 AND HAD SATISFACTORY STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention