BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2011515 · Received March 7, 2011

    Report

    Report Number
    3004209178-2011-01677
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 18, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFORMATION THERE WAS A REVISION DONE IN THE PAST TO REMOVE ONE LEAD, REASON FOR DOING THIS IS UNKNOWN AT THIS TIME. PATIENT CURRENTLY IS NOT RECEIVING PAIN COVERAGE. A REVISION IS PLANNED TO IMPLANT A NEW LEAD AND A NEW INS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT069987P| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# J0118483V| EXTENSION: MODEL 7495-25, LOT# NAF000872V| LEAD: MODEL 3487A, LOT# J0118483V| EXPLANTED:| EXTENSION: MODEL 7495-25, LOT# NAF000389V