BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1983023 · Received February 4, 2011

    Report

    Report Number
    3004209178-2011-00907
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    August 1, 2010
    Report Date
    January 20, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FLUID WAS COMING OUT OF THE IMPLANTABLE NEUROSTIMULATOR POCKET. IT WAS INFECTED. THE ENTIRE SYSTEM WAS REMOVED. THE PT WAS STILL HAVING SOME PAIN IN HER HIP.

    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 73 YR Required Intervention IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT010033N| EXTENSION: MODEL 7495-66, LOT# XS0002881N| LEAD: MODEL 3487A, LOT# L41304