BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3202693 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-02190
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    February 8, 2013
    Report Date
    June 10, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8590-1, LOT# N070172, IMPLANTED: 2006-(B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2006-(B)(6), (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER LATER REPORTED THAT THE PATIENT WAS HAVING SPINAL SURGERY AND THEY ACCIDENTALLY CUT THE CATHETER. THEY WERE NOT SURE WHAT IMMEDIATE ACTION THEY TOOK TO CORRECT IT. IT WAS RECOMMENDED THAT FOLLOW-UP BE CONDUCTED WITH THE SURGEON TO FIND OUT. THE PATIENT HAD SALINE PUT IN THEIR PUMP ON (B)(6) 2013 SO THEY COULD KEEP IT RUNNING AS THEY ¿DID NOT WANT TO RUIN THE PUMP¿. THE PUMP WAS CURRENTLY NEAR END OF LIFE, AND IT WAS TO BE REPLACED ON (B)(6) 2013. THEY WILL TRY TO REVISE THE CATHETER BY SPLICING IT, BUT IF THAT DOES NOT WORK THEY WILL JUST PUT A NEW ON IN. PRIOR TO SALINE, THE PATIENT HAD 20 MG/ML OF MORPHINE AT A DAILY INFUSION RATE OF 19 MG/DAY. ANOTHER HEALTHCARE PROVIDER LATER REPORTED THAT THE PATIENT HAD A LUMBAR RECONSTRUCTIVE SURGERY (ALSO NOTED TO BE A SCOLIOSIS SURGERY) AND FUSION OF L2-L5 ¿ABOUT TWO WEEKS PRIOR TO (B)(6) 2013¿. THE PATIENT WAS ADMITTED ON (B)(6) 2013 AND DISCHARGED ON (B)(6) 2013. DURING THE PROCEDURE, THE PATIENT¿S CATHETER ¿CAME OUT¿, AND THE SURGEON DECIDED TO LIGATE THE END OF THE CATHETER WHICH WAS ATTACHED TO THE PUMP. IN THIS REGARD, THE PATIENT HAD DIFFICULTY FOLLOWING THE SURGERY FOR HER PAIN CONTROL. THE PATIENT¿S PHYSICAL THERAPY PROGRESS WAS ¿VERY SLOW¿. THEIR PAIN STATUS GRADUALLY GOT BETTER WITH HEAVY NARCOTIC MEDICINE. ON (B)(6) 2013 THE PATIENT WAS DISCHARGED AND SENT TO REHAB WITH HER DRAIN IN. THEY WERE ENCOURAGED TO DO AEROBIC-TYPE ACTIVITY AND WALKING. THE PATIENT DEVELOPED SOME PUFFINESS AND SWELLING IN THEIR LUMBAR INCISION. THE PATIENT CONTINUED TO HAVE PAIN AND DISCOMFORT IN THEIR LOWER BACK. THE PATIENT CAME INTO THE OFFICE WITH THE DIAGNOSIS OF A POSTOPERATIVE SEROMA. AN MRI SHOWED A POSTOPERATIVE SEROMA/HEMATOMA AND RIGHT-SIDED FORAMINAL STENOSIS OF L1-L2. THEY DECIDED TO PROCEED WITH SURGICAL INTERVENTION, AND THE HEMATOMA OR SEROMA STARTED FOLLOWING THE PATIENT¿S DRAIN WHICH ¿CAME OUT ACCIDENTALLY¿ AT A HEALTHCARE FACILITY. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM WITH GOOD GENERAL CONDITION. ON 2/21/2013 THE PATIENT¿S PAIN WAS DOING A LITTLE BETTER, AND THEY WERE AFEBRILE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT PUMP SURGERY FOR NORMAL ERI TOOK PLACE ON (B)(6) 2013. DURING SURGERY THEY USED FLUOROSCOPY TO VISUALIZE THE CATHETER BUT COULD NOT DETERMINE WHERE THEY NEEDED TO SPLICE AND REPAIR IT SO THE OLD CATHETER WAS REMOVED AND A NEW CATHETER WAS REPLACED. THE OLD CATHETER WAS DISPOSED OF AND NOT MARKED FOR RETURN. THE PATIENT HAD BEEN GETTING IMPROVED THERAPY, HOWEVER THEY WERE INCREASING HER DOSE SLOWLY. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE HEALTHCARE PROVIDER ACKNOWLEDGED THEY WANTED THE PUMP TO BE TURNED OFF AND REQUESTED THE PASSWORD TO DO SO. A REPRESENTATIVE REPORTED THAT THE PATIENT HAD NORMAL SALINE IN THEIR PUMP SINCE (B)(6) 2013 BECAUSE THEIR CATHETER GOT CUT WITH THE SURGERY. THE SURGERY WHERE THE CATHETER WAS CUT WAS UNRELATED TO THE INFUSION SYSTEM, AND IT WAS NOTED TO BE A SPINAL FUSION SURGERY WHICH OCCURRED ON (B)(6) 2013. THE PATIENT HAD ¿SOME OTHER SURGERIES AND WHATNOT¿. THE PATIENT¿S EARLY REPLACEMENT INDICATOR WAS PENDING, AND THE PATIENT WAS DUE FOR REPLACEMENT ON (B)(6) 2013. THIS WAS NOTED TO BE NORMAL. THE PASSWORD FOR SHUTTING THE PUMP OFF WAS PROVIDED. THE REPRESENTATIVE LATER REPORTED THAT, AS OF 6/19/2013, THE PATIENT HAD NORMAL SALINE IN THEIR PUMP AT MINIMAL RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300818 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Required Intervention