BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1840083 · Received September 15, 2010

    Report

    Report Number
    3007566237-2010-07004
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 16, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOTOR STALL WAS CONFIRMED BY THE PATIENT PROGRAMMER. AN ALARM WAS HEARD AND CONFIRMED BY TELEMETRY. THE ALARM WAS DUE TO A MOTOR STALL THAT OCCURRED ON (B)(6) 2010. THE STALL WAS CONSTANT AND NO RECOVERY WAS RECORDED. THE MEDICATION IN THE PUMP INCLUDED THE FOLLOWING DRUGS: NEURONTIN WITH A CONCENTRATION OF 2.5MG/ML; FENTANYL WITH A CONCENTRATION OF 250MCG/ML; AND BACLOFEN WITH A CONCENTRATION OF 15 MCG/ML. THE DOSAGE WAS UNK. PATIENT'S STATUS WAS UNAVAILABLE AT THE TIME OF REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE MADE AS FOLLOW UP AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male CATHETER: MODEL #8709, LOT #L78001.| CATHETER: MODEL #8711, LOT #J11512R12.| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL #8711, LOT #J11512R12| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL #8709, LOT #L78001