BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202178 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-00074
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    March 29, 2012
    Report Date
    April 5, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0592-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PUMP WAS INTERROGATED ON (B)(6) 2012 AND IT SHOWED MOTOR STALLS OCCURRED. TEN MINUTES AFTER THE MOTOR STALL, A RECOVERY WAS NOTED. AN HOUR LATER, THE MOTOR STALLED AGAIN AND IT SAID ¿PUMP STOPPED PERIOD MAY EXCEED¿ ON (B)(6) 2012 BECAUSE ¿IT WAS NEVER RECOVERED AT THAT TIME¿. NO ALARM WAS HEARD. MOTOR STALLS CAUSED BY PATIENT HAVING MAGNETIC RESONANCE IMAGING FOR A SEVERE HEADACHE, WHICH WAS LATER REPORTED TO BE UNRELATED TO DEVICE OR THERAPY. THE MOTOR STALL WAS RECOVERED ON THE DATE OF THIS REPORT. IT WAS NOTED THAT ¿THE MRI WAS NORMAL AND EVERYTHING WAS IN PLACE.¿ THE PATIENT WAS ¿DOING FINE AND RECEIVING EFFECTIVE THERAPY.¿ THE PUMP WAS USED TO DELIVER MORPHINE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PUMP ¿DID NOT TURN BACK ON AS HE EXPECTED¿. THE PATIENT HAD GONE TO HIS HEALTHCARE PROVIDER (HCP) AND STATED THAT HIS PUMP HAD ONLY ¿2 DAYS LEFT BEFORE IT WOULD HAVE SHUT OFF FOR GOOD¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303086 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR