BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2092124 · Received April 27, 2011

    Report

    Report Number
    3004209178-2011-03130
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    October 1, 2010
    Report Date
    April 8, 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
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND NO STIMULATION SENSATION. THE ISSUES BEGAN ABOUT SIX MONTHS PRIOR TO THE DATE OF THE REPORT WITH STIMULATION BEING INTERMITTENT THEN STOPPING ALTOGETHER. IT WAS NOTED THAT THE PATIENT HAD A SLIP ON THE ICE. BUT IT WAS NOT CLEAR THAT THE TIME FRAME CORRELATED. IT WAS ALSO NOTED THAT THE PATIENT PREVIOUSLY HAD ONE LEAD "QUIT", AND REPROGRAMMING WAS ABLE TO RESOLVE THE ISSUE. THE STATUS LIGHTS WERE ASSESSED ON THE PATIENT PROGRAMMER, AND INDICATED THE STIMULATION WAS ON AND THE INTERNAL BATTERY WAS GOOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 57 YR LEAD: MODEL 3890, LOT# J0427841V| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU063974V| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU034535V| LEAD: MODEL 3890, LOT# J0444037V| EXPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT045594P| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED: