BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4111304 · Received September 23, 2014

    Report

    Report Number
    3007566237-2014-02672
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0591-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). <(>&<)> THE PREVIOUSLY CHECKED RECALL, NOTIFICATION AND CORRECTION NUMBER ARE NO LONGER APPLICABLE TO THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE DELIVERED GABLOFEN. THE PATIENT'S LAST REFILL HAD BEEN ON (B)(6) 2014. THE MOTOR STALL DID RECOVER. IN REVIEW OF THE LOGS, THERE WAS A MOTOR STALL AND MOTOR RECOVERY ON (B)(6) 2014. THE PUMP WAS STALLED FOR LESS THAN 2 HOURS. THE PATIENT HAD CALLED THE OFFICE ON THAT DATE AS SHE HEARD THE ALARM. SHE HAD NOT UNDERGONE A MRI. THERE WERE NO FURTHER INCIDENCES OF THE ALARM SOUNDING AFTER THAT DATE AND THERE WAS NOT MORE THAN ONE STALL NOTED IN THE LOGS. THE PATIENT HADN'T BEEN AROUND ANY DEVICES THAT SHE WAS AWARE OF THAT MAY HAVE CAUSED THE MOTOR TO STALL. THE HEALTH CARE PROVIDER (HCP) INSTRUCTED THE PATIENT TO LET THE HCP OFFICE KNOW IF SHE HEARD HER ALARM AGAIN OR IF SHE HAD ANY UNDERDOSE OR OVERDOSE SYMPTOMS. IN TERMS OF WHAT ACTIONS WERE TAKEN, THE PATIENT WAS BEING MONITORED FOR WITHDRAWAL SYMPTOMS OR FURTHER ALARMS. THE PATIENT WAS AT THE TIME OF THIS SUPPLEMENTAL REPORT DOING WELL WITH NO ISSUES OR COMPLAINTS SINCE THE INCIDENT AND WAS RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    A FALSE MOTOR STALL AND TELEMETRY STATE RELATED TO AN MRI WERE REPORTED. THE ISSUE WAS NOT RESOLVED, AND THE CAUSE OF THIS ISSUE WAS NOT DETERMINED. IT WAS UNKNOWN IF THE STALL RECOVERED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PUMP CONTAINED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590281 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1