BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1935950 · Received December 3, 2010

    Report

    Report Number
    3007566237-2010-10195
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE HEALTHCARE PROFESSIONAL HAD DIFFICULTY REMOVING THE GUIDEWIRE OUT OF THE TWO CATHETERS. AFTER THE GUIDEWIRE WAS REMOVED IT WAS NOTED THAT BOTH CATHETERS HAD A LEAK IN THE MIDDLE. THE TWO CATHETERS WERE USED TO BUILD ONE CATHETER WHICH WAS IMPLANTED SUCCESSFULLY. THE DRUG USED WAS BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT # 0204204747| CATHETER: MODEL 8709SC, LOT # 0203955105