BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2961053 · Received February 14, 2013

    Report

    Report Number
    3007566237-2013-00478
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    June 6, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# UNKNOWN. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SYSTEM SEEMED TO BE WORKING FINE AND THERE WAS NO EVIDENCE OF OCCLUSION ON REFILLS AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    THE ACTUAL RESIDUAL PUMP VOLUME WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME. IT WAS BELIEVED THAT THIS WAS THE FIRST REFILL AFTER IMPLANT AND THAT 20 ML WAS PULLED FROM THE PUMP; THE AMOUNT EXPECTED WAS UNKNOWN. THE IMPLANTING SURGEON SUSPECTED A CATHETER KINK BECAUSE THE PATIENT HAD A DIFFICULT ANATOMY AND THEY HAD TO DO "SPECIAL THINGS" TO GET THE CATHETER IMPLANTED IN (B)(6). THEY WERE UNSURE THOUGH SO ALSO WANTED TO RULE OUT AN ISSUE WITH THE PUMP. THEY DIDN'T SEE ANY MESSAGES WHEN INTERROGATING THE PUMP, SO WERE CONSIDERING A ROLLER STUDY ONCE THEY DISCONNECTED THE CATHETER FROM THE PUMP. THE DEVICE SYSTEM WAS DELIVERING BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE HEALTHCARE PROVIDER (HCP) DID NOT THINK THE PATIENT EVER HAD RECEIVED RELIEF OF HIS SPASTICITY. THERE WERE NO ALARMS ON THE PUMP LOGS. A SURGEON OPENED THE PUMP POCKET AND DISCONNECTED THE SUTURELESS CONNECTOR FROM THE PUMP. THERE WAS NO CEREBROSPINAL FLUID (CSF) OR DRUG FLOW FROM THE CATHETER. THERE WAS NO FLUID IN THE PUMP POCKET. THE SURGEON CUT THE CATHETER BEYOND THE SC AND OBSERVED FLOW FROM THE CATHETER. 4 CM OF CATHETER WAS REMOVED. 4 CC WERE ASPIRATED FROM THE CATHETER WITH A BLUNT NEEDLE AND ANGIOGRAPHIC CATHETER AND THEN DYE WAS INJECTED. THE SURGEON WAS HAPPY WITH THE CATHETER PLACEMENT AND CONTINUITY OBSERVED UNDER FLUOROSCOPY. THE SC WAS REPLACED WITH A NEW SECTION AND CSF FLOW WAS OBSERVED BEFORE ATTACHING TO THE PUMP. THE SURGEON COMMENTED THAT THE SC CONNECTOR MAY HAVE BEEN ON THE PUMP "CROOKED AND MAY HAVE PUSHED IN ON ONE SIDE."

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS PREVIOUSLY REPORTED IN MANUFACTURER'S REPORT #3007566237-2013-00521: IT WAS REPORTED THE PATIENT HAD A NEW PUMP IMPLANTED SOMEWHERE BETWEEN SEPTEMBER AND DECEMBER. WHEN THE PATIENT ATTENDED HIS FIRST AND/OR SECOND REFILL APPOINTMENT, THE PHYSICIAN ASPIRATED APPROXIMATELY THE SAME REFILL VOLUME OUT OF PUMP (THOUGHT IT WAS 20ML), AND IT WAS THOUGHT THAT THE PATIENT NEVER HAD RECEIVED RELIEF OF HIS SPASTICITY. THE PUMP LOGS WERE READ ON (B)(6) 2013 BY THE SURGEON, AND THE LOGS DID NOT SHOW ANY ABNORMAL MESSAGES, SUCH AS MOTOR STALL. THE SURGEON OPTED NOT TO DO A ROLLER STUDY. THE SURGEON OPENED THE PUMP POCKET, DISCONNECTED SC CONNECTOR FROM THE PUMP, AND DID NOT OBSERVE ANY CSF/DRUG (CEREBRAL SPINAL FLUID) FLOW FROM CATHETER. NO FLUID WAS NOTED TO BE PRESENT IN THE PUMP POCKET. THE SURGEON CUT THE CATHETER BEYOND SC CONNECTOR/CATHETER CONNECTION AND OBSERVED THE CSF FLOW FROM THE CATHETER. ABOUT 4 ML WAS ASPIRATED FROM CATHETER WITH A BLUNT NEEDLE AND AN ANGIOCATH DYE WAS INJECTED INTO THE CATHETER. THE SURGEON WAS HAPPY WITH THE CATHETER POSITION/CONTINUITY THAT WAS OBSERVED ON FLUOROSCOPY. THE SURGEON OPTED TO TIE SUTURES AROUND NEW CATHETER/CONNECTOR COMPONENT THAT HE USED AS REPLACEMENT. CSF FLOW WAS OBSERVED TO BE COMING OUT OF THE END OF THE CATHETER. FOUR CENTIMETERS WERE TRIMMED FROM THE CATHETER PRIOR TO PROGRAMMING A PRIMING BOLUS. THE SURGEON SUSPECTED THAT THE CATHETER CONNECTOR MAY HAVE BEEN ON THE PUMP "CROOKED AND MAY HAVE BEEN PUSHED IN ON ONE SIDE." THE PATIENT¿S DOSE WAS PROGRAMMED TO 300 MCG/DAY SIMPLE CONTINUOUS FLOW RATE. THE PUMP WAS DELIVERING LIORESAL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SUTURELESS CATHETER CONNECTOR WAS SUSPECTED TO HAVE OCCLUDED THE FLOW OR THE CATHETER WAS ON ¿CROOKED.¿ THE PATIENT OUTCOME REMAINS UNKNOWN.] ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS DOING WELL FOLLOWING THEIR CATHETER REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66069 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention