BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2190427 · Received July 25, 2011

    Report

    Report Number
    9614453-2011-05726
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT FEELING A STIMULATION SENSATION AND ALL IMPEDANCES WERE OVER 10,000 OHMS. IMPEDANCES ON THE FIRST DAY FOLLOWING IMPLANT WERE WITHIN THE RANGE OF 1042-3684 OHMS. TWO DAYS LATER, THEY RANGED FROM 601-1884 OHMS. THREE DAYS LATER THEY WERE 3260 TO >4000 OHMS. THE FOLLOWING DAY ALL BUT ONE ELECTRODE WAS >4000 OHMS. THERE WAS NO NEUROLOGICAL RESPONSE WITH AMPLITUDES TESTED UP TO 10.5V. IT WAS NOTED THAT BLOOD AND OTHER FLUIDS WERE VISIBLE IN THE EXTENSION AND HEADER OF THE NEUROSTIMULATOR. THE EXTENSIONS APPEARED "BLACKENED" AT THE LEAD - EXTENSION CONNECTION SITE. THE IMPLANTED NEUROSTIMULATOR AND EXTENSIONS WERE EXPLANTED AND REPLACED ON (B)(6) 2011. THE LEADS WERE TESTED USING A MULTI-LEAD TRAILING CABLE AND WERE WORKING OKAY. AFTER REPLACEMENT THE IMPEDANCES WERE NORMAL AND THE NEUROLOGICAL RESPONSE WAS GOOD. THE PATIENT RECOVERED WELL W/O COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MEDTRONIC EUROPE SARL 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU225742V| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU225743V| EXPLANTED: