BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1980370 · Received February 3, 2011

    Report

    Report Number
    3004209178-2011-00854
    Event Type
    Injury
    Date Received
    February 3, 2011
    Date of Event
    August 16, 2010
    Report Date
    January 5, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001/S42
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD THEIR NEUROSTIMULATOR REPLACED BECAUSE IT DID NOT OFFER RELIEF. SINCE THE REPLACEMENT SURGERY, THE PT HAD NO PAIN AND GOOD COVERAGE.

    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 65 YR Required Intervention LEAD: MODEL 3887, LOT# J0519335V| LEAD: MODEL 3887, LOT# J0519335V| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU072288V| EXTENSION: MODEL 7489, LOT# NHU089194V| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED: