BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2566051 · Received May 9, 2012

    Report

    Report Number
    3004209178-2012-03123
    Event Type
    Injury
    Date Received
    May 9, 2012
    Report Date
    April 12, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVIEW DETERMINED THAT WHILE SERIOUS, THE SYMPTOMS REPORTED DID NOT INDICATE A LIFE THREATENING EVENT. LIFE THREATENING WAS INCORRECTLY CHECKED ON THE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    EXTENSION MODEL 748940 (B)(4) IMPLANTED: 2006-(B)(6) EXPLANTED: NA. EXTENSION MODEL 748940 (B)(4) IMPLANTED: 2006-(B)(6) EXPLANTED: NA. PROGRAMMER MODEL 7435 (B)(4). LEAD MODEL 399930 LOT# V002125 IMPLANTED: 2006-(B)(6) EXPLANTED: NA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN ALLERGIC REACTION FOR THE "LAST 6 MONTHS." THE CAUSE HAD NOT BEEN DETERMINED DESPITE TESTING FROM DIFFERENT PHYSICIANS. THE PATIENT HAD SWELLING IN HIS LIPS AND EYES, HIVES, AND BACK/CHEST PAIN. THE PATIENT WAS CONCERNED THAT THE DEVICE COULD BE LEAKING A SUBSTANCE INTO HIS BLOODSTREAM. 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 MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening