BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1961103 · Received January 12, 2011

    Report

    Report Number
    3004209178-2011-00318
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    August 1, 2010
    Report Date
    October 14, 2010
    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). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETED. THIS REPORT IS BEING SENT FOLLOWING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT, WITH A LOSS OF STIMULATION SENSATION. THE SYMPTOMS OCCURRED FOLLOWING A FALL EARLIER IN THE WEEK. THE DETAILS OF THE FALL WERE UNK. IT WAS FURTHER REPORTED THAT IMPEDANCE TESTING SHOWED READINGS GREATER THAN 4,000 OHMS ON SOME OF THE BIPOLAR PAIRS. ADDITIONAL INFO RECEIVED REPORTED THAT THE PT HAD TAKEN SEVERAL FALLS AND HAD MOST LIKELY DAMAGED HIS LEADS THAT WAY. FURTHER INFO RECEIVED REPORTED THAT THE WHOLE SYSTEM WAS REPLACED BECAUSE THE PT HAD FALLEN (MULTIPLE TIMES) AND THE LEADS WERE "OUT". THE PT RECOVERED WELL AND WAS USING HIS NEW SYSTEM. IT WAS UNCLEAR WHICH SYSTEM WAS RELATED TO THE ISSUE AS BOTH WERE REPLACED. REFERENCE MFR REPORT# 3004209178-2010-07449.

    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 68 YR Required Intervention EXPLANTED:| LEAD: MODEL 3487A, LOT# J0110849V| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3487A, LOT# L45962| LEAD: MODEL 3487A, LOT# J0104098V| IMPLANTED:| LOT# NFE143849H| LEAD: MODEL 3778, LOT# V029710034| PROGRAMMER: MODEL 7435, LOT# NFT012874P| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0043853N| IMPLANTABLE NEURO STIMULATOR: MODEL 7427,| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7472, LOT# NJK001238N| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| UNK CONVERSION TYPE: MODEL 3550-09, LOT# L93809| PROGRAMMER: MODEL 7435, LOT# NFT056002P