BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNERGY

    MDR report key: 577954 · Received March 1, 2005

    Report

    Report Number
    3004209178-2005-00329
    Event Type
    Other
    Date Received
    March 1, 2005
    Date of Event
    June 2, 2004
    Report Date
    February 4, 2005
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., MEDREL
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HCP REPORTED PT PRESENTED IN 2004 WITH SIGNS OF A WOUND INFECTION AFTER SLIPPING IN THE MUD WHILE CLEANING AN ABOVE GROUND POOL. HCP REPORTED PT WAS TREATED WITH ANTIBIOTICS AND DEVICE REMOVAL 2004. THE DEVICE WAS RETURNED TO THE MFR FOR ANALYSIS HCP REPORTED PT RECOVERED AND IPG WAS REPLACED JANUARY 2005.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other EXPLANTED: UNK| EXTENSION MODEL 7495-51 LOT# XR0052907N IMP:1998| EXPLANTED: UNK| LEAD MODEL 3487A LOT# L55268 IMP: 1998