BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1850916 · Received September 29, 2010

    Report

    Report Number
    3004209178-2010-07415
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 1, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD NO IMPROVEMENT IN SYMPTOMS FOLLOWING IMPLANTATION OF THE NEUROSTIMULATOR. INTERROGATION WAS PERFORMED MANY TIMES DURING THE IMPLANT PERIOD AND SHOWED THE DEVICE WAS WORKING PROPERLY. IMPEDANCES WERE NORMAL. THE PHYSICIAN NOTED THAT THE PATIENT WAS DIABETIC AND DID NOT TAKE PROPER POST-OPERATIVE CARE THUS CAUSING AN INFECTION. THE INFECTION WAS UNABLE TO BE CONTROLLED AND THE DEVICE SYSTEM WAS REMOVED. THE PATIENT'S CONDITION RETURNED TO THE PRE-OPERATIVE STATE AND WAS NOTED THAT HE HAD TO TAKE "A LOT OF DRUGS". NO PATIENT INJURIES WERE REPORTED.

    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 55 YR Required Intervention