BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3930167 · Received July 11, 2014

    Report

    Report Number
    3004209178-2014-12927
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 21, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A MOTOR STALL AND MOTOR STALL RECOVERY RECORDED IN THE EVENT LOGS. THE MOTOR STALL WAS CAUSED BY THE PATIENT HAVING AN MRI OR OTHER MEDICAL PROCEDURE. THE PATIENT EXPERIENCED SIGNIFICANTLY WORSE SPASTICITY. THE HEALTH CARE PROVIDER (HCP) DID NOT KNOW WHEN THE SYMPTOMS FIRST STARTED AFTER THE MRI. THE HCP NOTED, THE PATIENT SYMPTOMS WERE NOT THERE YESTERDAY WHEN THE PATIENT HAD THE MRI. THE PUMP WAS INTERROGATED THE MORNING OF THE REPORT AND THERE WAS A MOTOR STALL IN THE EVENT LOGS WITH NO RECOVERY. A LITTLE WHILE AFTER THE PUMP WAS UPDATED AGAIN AND THE LOGS WERE CHECKED AND A MOTOR STALL RECOVERY WAS SHOWING IN THE LOGS. IT WAS THOUGHT THE PUMP HAD STALLED ALL NIGHT FOLLOWING THE MRI AND THE PATIENT HAD SYMPTOMS WHEN HE CAME IN THE MORNING OF THE REPORT TO GET THE PUMP CHECKED. THE SYSTEM WAS BEING USED TO DELIVER LIORESAL. TWO DAYS LATER, IT WAS REPORTED, THE MOTOR STALL WAS AT 6PM AND THE PATIENT HAD A ROUGH NIGHT WITH RETURN OF SPASTICITY. THE PUMP WAS INTERROGATED AT 8AM AND THERE WAS A MOTOR STALL AT 6:15 BUT NO RECOVERY UNTIL 8:16AM AFTER THE PUMP WAS INTERROGATED. IT WAS LATER REPORTED THE MRI WAS PERFORMED ON 2014 (B)(6) AND THE HCP WAS NOT INFORMED TO INTERROGATE THE PUMP. THE MORNING THAT THE PUMP WAS INTERROGATED AND THE STALL RECOVERED THE PATIENT WAS DEMONSTRATING RETURNED SEVERE RIGIDITY IN THE LOWER EXTREMITIES WHICH WAS PREVIOUSLY WELL TREATED WITH INTRATHECAL BACLOFEN. OVER THE NEXT SEVERAL HOURS THE PATIENTS SYMPTOMS SLOWLY BEGAN TO LESSEN. BY 24 HOURS LATER, THE PATIENT WAS CLOSE TO HIS PREVIOUS BASELINE. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406142 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR