BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2459854 · Received February 17, 2012

    Report

    Report Number
    3004209178-2012-01046
    Event Type
    Malfunction
    Date Received
    February 17, 2012
    Report Date
    January 20, 2012
    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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: LEAD MODEL 3889-28 LOT J0349006V IMPLANTED: (B)(6) 2003 EXPLANTED: NA. LEAD MODEL 3889-28 LOT J0348820V IMPLANTED: (B)(6) 2003 EXPLANTED: NA. EXTENSION MODEL 3095-10 SERIAL (B)(4) IMPLANTED: (B)(6) 2003 EXPLANTED: NA. EXTENSION MODEL 3095-10 SERIAL (B)(4) IMPLANTED: (B)(6) 2003 EXPLANTED: NA. PROGRAMMER MODEL 7435 SERIAL (B)(4). NEUROSTIMULATOR MODEL 37711 SERIAL (B)(4) IMPLANTED: (B)(6) 2009. LEAD MODEL 3776-60 SERIAL (B)(4) IMPLANTED: (B)(6) 2009 EXPLANTED: NA. LEAD MODEL 3776-60 SERIAL (B)(4) IMPLANTED: (B)(6) 2009 EXPLANTED: NA. RECHARGER MODEL 37752 SERIAL (B)(4). PROGRAMMER MODEL 37743 SERIAL (B)(4).

    Description of Event or Problem · 1

    PLEASE SEE MFR #6000032-2012-00052. INFORMATION RECEIVED ON (B)(4) 2012 CLARIFIED THAT THIS DEVICE WAS FOR THE URINARY SYSTEM. ALL FURTHER INFORMATION WILL BE FILED UNDER 6000032-2012-00052.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN OVERSTIMULATION SENSATION, AS WELL AS OTHER SENSATIONS, FOLLOWING A FALL 2-3 WEEKS PRIOR TO THE REPORT. THE IMPLANTS "GOT TURNED ON TO MAX" AND WERE "KILLING" THE PATIENT. THE IMPLANTS "ZAPPED THE LIFE OUT" OF HER. ONE DEVICE REPORTEDLY "WENT DEAD." THE PATIENT ALSO HAD A "TIC" FROM THE TOES UP TO THE LEG, CROSSING TO THE OTHER LEG. THE SYSTEMS WERE NOT CHECKED AFTER THE FALL. IT WAS FOUND THAT THE SYSTEMS WERE OFF DURING THE REPORT OF THE SYMPTOMS, AND THE PATIENT WAS FEELING "JERKY." ADDITIONAL INFORMATION WAS REQUESTED.

    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