BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2190392 · Received July 25, 2011

    Report

    Report Number
    3004209178-2011-05739
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF IMPLANTABLE NEUROSTIMULATOR (INS) MODEL 7427 (B)(4) DETERMINED THAT THE BOND WIRE WAS BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE STIMULATION IS ON THERE WAS NO STIMULATION SENSATION. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. IT WAS REPORTED THAT THE PATIENT NEEDED GENERATOR REPLACEMENT. THE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention IMPLANTED:| EXPLANTED:| LEAD: MODEL 3998, LOT# J0519307V| IMPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT025912P| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495LZ, LOT# NHK022568V| EXPLANTED:| EXTENSION: MODEL 7495LZ, LOT# NHK012913V