BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2162073 · Received July 12, 2011

    Report

    Report Number
    3004209178-2011-05341
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE EMERGENCY ROOM (ER) AFTER EXPERIENCING A SHOCKING OR JOLTING SENSATION. THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR WAS TURNED OFF PER PHYSICIAN'S DIRECTIONS. THERE WAS NO SHOCKING SENSATION WITH THE STIMULATION TURNED OFF. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED AN OVERSTIMULATION SENSATION WITH THE DEVICE TURNED ON. ADDITIONAL INFORMATION REPORTED THAT THE PATIENT'S STIMULATION WAS "TOO STRONG" IN THE VAGINA WHEN VOIDING. THE PATIENT HAD A URINARY TRACT INFECTION. THE CAUSE OF THE SHOCKING AND OVERSTIMULATION SENSATIONS WERE UNKNOWN, BUT POSSIBLE DUE TO "TOO MUCH STIMULATION." ALL IMPEDANCE READINGS WERE WITHIN NORMAL LIMITS. THE PATIENT'S DEVICE WAS REPROGRAMMED ON (B)(6) 2011. THE LEFT SIDE WAS CHANGED FROM 0-, 1+ TO 2-, 3+. THE RIGHT SIDE WAS CHANGED FROM 4+, 5- TO 4-, 6+. THE PULSE WIDTH WAS CHANGED FROM 210 TO 240. THE RATE WAS CHANGED FROM 15 TO 20. THE PATIENT, SUBSEQUENTLY, "FELT COMFORTABLE STIMULATION." THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY EZW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention LEAD: MODEL 3093, LOT# V008491| EXTENSION: MODEL 7489, LOT# NHU120358V| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT# V008491| PROGRAMMER: MODEL 7435, LOT# NFT060163P| EXTENSION: MODEL 7489, LOT# NHU131518V| IMPLANTED: