BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2193639 · Received July 14, 2011

    Report

    Report Number
    3007566237-2011-05446
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUMP AND CATHETER HAVE BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS ALARMING DUE TO MOTOR STALL. THE PUMP LOGS SHOWED A MOTOR STALL ON (B)(6) 2011 WITH RECOVERY ON (B)(6) 2011, AND ANOTHER MOTOR STALL ON (B)(6) 2011 WITH NO RECOVERY. THE PATIENT DID NOT HAVE A RECENT MRI OR OTHER OCCURRENCE. THE PUMP LOGS SHOWED THE ESTIMATED REPLACEMENT INDICATOR TO BE NINE MONTHS. A PUMP REPLACEMENT WAS SCHEDULED. ON THE DAY OF SURGERY, THE PUMP WAS NOT ALARMING. DURING SURGERY PREPARATION, THE HEALTH CARE PROVIDER (HCP) USED THE CATHETER ACCESS PORT KIT TO ACCESS THE CATHETER TO SEE IF THE CATHETER WAS PATENT, BUT WAS UNABLE TO ASPIRATE THE CATHETER. THE PATIENT WAS PLACED IN LATERAL POSITION AND PREPPED FOR SURGERY. THE HCP OPENED THE PUMP POCKET SITE, ACCESSED THE PUMP AND TRIED ONCE AGAIN TO ASPIRATE THE CATHETER WITHOUT SUCCESS. THE PUMP AND CATHETER WERE REPLACED. ORAL MEDICATION SUPPLEMENTATION HAD BEEN SUGGESTED DURING THIS EVENT. IT WAS REPORTED BY THE HCP THAT THE DRUGS INFUSED VIA THE PUMP INCLUDED MORPHINE 5MG/ML AND BACLOFEN 50MG/ML.

    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 48 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8709, LOT# J12438R22| EXPLANTED: