BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2990392 · Received March 5, 2013

    Report

    Report Number
    3007566237-2013-00682
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    March 14, 2006
    Report Date
    June 5, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8731, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: CATHETER; PRODUCT ID: 8731. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8731, SERIAL/LOT #: (B)(4), UBD: (B)(6) 2008, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS DISCONNECTED FROM THE OLD PUMP DURING A REPLACEMENT FOR NORMAL BATTERY DEPLETION/END OF LIFE (EOL). THEY TRIED TO ASPIRATE USING A TB SYRINGE TO CHECK FOR CATHETER PATENCY. IT WAS THOUGHT THAT THE HEALTH CARE PROVIDER (HCP) PULLED BACK 0.15 MILLILITERS (ML) OF FLUID. THE CATHETER VOLUME WAS 0.197. A DYE STUDY WAS GOING TO BE PERFORMED TO CHECK THE CATHETER PATENCY. THE PATIENT HAD COMPLAINED ABOUT THERAPY SINCE IMPLANT; THAT THEY NEVER HAD THERAPEUTIC EFFECT. THE PUMP WAS REPORTED TO BE DELIVERING BUPIVACAINE, PRIALT AND DILAUDID. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS NEVER PRESCRIBED PRIALT. THE DOSAGES OF THE DRUGS WERE NOT AVAILABLE. THE PATIENT WAS HAVING POOR PAIN CONTROL BEFORE THE PUMP REPLACEMENT. THE CATHETER WAS A LITTLE "SLUGGISH" WHEN THE PHYSICIAN WAS TRYING TO DRAIN IT, BUT HE FINALLY DRAINED ABOUT 1/2 CUBIC CENTIMETER (CC). THE PHYSICIAN THEN FLUSHED IT WITH NORMAL SALINE AND IT STARTED FLOWING VERY WELL. HE HAD GOOD CEREBRAL SPINAL FLUID (CSF) FLOW. THE CATHETER WAS NOT REPLACED OR REVISED. THE PATIENT RECEIVED THE NEW PUMP AND DID WELL DURING SURGERY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) INDICATED HE OPERATED ON HER (B)(6) 2012 AND REPLACED HER PUMP. HE STATED THAT THE CATHETER WAS NOT DRAINING READILY BUT SALINE WAS INJECTED INTO THE CATHETER AND HE FELT THAT A GOOD FLOW WAS ESTABLISHED. THE DRUG MIXTURE FROM THE OLD PUMP WAS REMOVED AND 20CC WERE REPLACED. HE STATED THAT SHE RESPONDED WELL AFTER THE PROCEDURE AND RESPONDED WELL TO MEDICATION INJECTIONS. THE HCP ONLY SAW HER (B)(6) 2012, AND THERE WAS SOME SWELLING AROUND THE LUMBAR AREA AND THE FAMILY HAD QUESTIONS ABOUT THE CATHETER, BUT IT WAS NOTED THAT THERE WAS GOOD FLOW AT SURGERY AND SHE WAS RECEIVING GOOD TREATMENT SO AT THAT TIME THEY WERE NOT PLANNING FOR REOPERATION. THE HCP TOLD THE PATIENT TO WEAR HER BINDER AS LONG AS SHE HAD SWELLING 24-7 AND HE WAS GOING TO REASSESS HER ON A REGULAR BASIS HER AS NEEDED. THE LAST TIME THE HCP SAW HER WAS (B)(6) AND AT THAT TIME THE MEDICATION LEVEL WAS WORKING SATISFACTORY AND SHE WAS GETTING SATISFACTORY PAIN RELIEF. HE STATED THAT SHE STILL HAD SOME QUESTIONS ABOUT THE LUMBAR SITE AND THE SWELLING ALONG THE RIGHT FLANK AND UPON EXAMINATION IT WAS DETERMINED THE PUMP WAS WORKING FINE AND HE RECOMMENDED THAT SHE CONTINUE WEARING THE BINDER AS LONG AS SHE HAD THOSE CONCERNS/COMPLAINTS. HE STATED THAT THE PATIENT SUGGESTED THAT THEY HAD DISCUSSED A DYE TEST AT SOME POINT, HOWEVER THE MOTHER AND PATIENT ACKNOWLEDGED THAT THE PATIENT WAS GETTING SATISFACTORY PAIN RELIEF GENERALLY AND WAS RELATIVELY SATISFIED WITH HER CONDITION AT THAT POINT ON (B)(6) 2012 AND THE HCP NEVER SAW HER AFTER THAT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED OR EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93573 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR