BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2160914 · Received June 16, 2011

    Report

    Report Number
    3007566237-2011-04510
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    January 1, 2008
    Report Date
    June 10, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IN EARLY (B)(6) 2011, IT WAS REPORTED THAT THE "PUMP FAILED 6 MONTHS AFTER IMPLANT." IT WAS NOTED THAT THE DOCTOR HAD LEFT THE MEDICATION IN THE PUMP, BUT IT WAS UNK IF THE PUMP HAD BEEN PROGRAMMED OFF OR NOT. THE PT HAD NO PUMP REFILLS SINCE THAT TIME. THE PT HAD BEEN DOING WELL FOR THE LAST 6 MONTHS; HE HAD BEEN VERY RELAXED AND WAS NOT HAVING TO TAKE ORAL BACLOFEN. THE PT'S MOTHER WAS WORRIED THAT THE PUMP CAME BACK ON AND WAS NOW EMPTY BECAUSE, FOR THE PAST 1.5 WEEKS, THE PT HAD INCREASED BASELINE SPASTICITY, SWEATING, AND A RAPID HEART (120, 127 AND 130). NO PUMP ALARMS HAD BEEN HEARD. THE PT WAS ASSESSED IN THE ER AND THEY WERE TOLD IT WAS HIS BOWELS AND CONSTIPATION; THE PT'S MOTHER REPORTED THAT PT HAD LOOSE STOOLS. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N133478032