BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2052659 · Received April 7, 2011

    Report

    Report Number
    3004209178-2011-02682
    Event Type
    Injury
    Date Received
    April 7, 2011
    Report Date
    March 22, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE DEVICE WAS RETURNED TO THE DEVICE MFR WITH NO INFO. THE HEALTH CARE PROFESSIONAL CONFIRMED THAT THE PT EXPERIENCED NO STIMULATION. THE INS FAILED AND WAS EXPLANTED. THE PT OUTCOME WAS NOTED AS NO INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROGRAMMER: MODEL 7435, LOT# NFT043046P| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# J0437184V| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU055681V| IMPLANTED:| UNK CONVERSION TYPE: MODEL 3550-09, LOT# LC1896