BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6290296 · Received January 31, 2017

    Report

    Report Number
    3004209178-2017-02176
    Event Type
    Injury
    Date Received
    January 31, 2017
    Date of Event
    October 1, 2015
    Report Date
    March 15, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169100824
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: CATHETER. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT TROUBLESHOOTING PERFORMED WAS A CT DYE STUDY AND DYE STUDY UNDER FLUOROSCOPY. IT WAS NOTED THAT THE PATIENT FIRST STARED EXPERIENCING THE NEED FOR A CATHETER REVISION ON (B)(6) 2015. THE PATIENT WAS SEEN (B)(6) 2016. THE PATIENT¿S MEDICAL HISTORY INCLUDED A C6 INCOMPLETE TETRAPLEGIA SECONDARY TO DIVING INTO A SHALLOW LAKE ON (B)(6) 2008. THE PATIENT UNDERWENT BACLOFEN PUMP PLACEMENT FOR SPASTICITY IN (B)(6) 2015. THE PATIENT HAD REQUESTED THE CATHETER BE PLACED AS HIGH AS POSSIBLE TO INCREASE THE EFFECT OF MEDICATION ON HIS ARMS. THE PATIENT HAD IMPROVEMENT IN SPASTICITY AND MUSCLE SPASMS AS HIS ITB DOSE WAS INCREASED. THE PATIENT WAS UNSURE OF THE EXACT TIMELINE BUT AROUND 3-5 MONTHS POST IMPLANTATION THE PATIENT REPORTED THAT THEIR SPASMS AND SPASTICITY STARTED TO INCREASE. THEY HAVE CONTINUED TO WORSEN SINCE THAT TIME DESPITE UPTITRATION OF THEIR ITB DOE. THE PATIENT WAS FOLLOWED AT UC FOR MANAGEMENT OF THE ITB PUMP, (PM <(>&<)>R AND NEUROSURGERY), INVESTIGATION OF PUMP/CATHETER TO THIS POINT HAS NOT SHOWN PROBLEM (NO PUMP ALARMS, NO MISMATCH ON PUMP VOLUMES WHEN REFILLED, SIDE PORT EASILY ASPIRATED, NORMAL FLOW OF CONTRA ST THROUGH CATHETER AND OUT TIP ON FLUOROSCOPY. THE PATIENT¿S NEUROSURGEON RECOMMENDS CT STUDY TO BETTER DEFINE WHERE THE CONTRAST WAS GOING ONCE LEAVING THE CATHETER AND WAS REFERRED FOR FLUOROSCOPY AND CONE BEAM CT STUDY. THE PATIENT UNDERWENT FLUOROSCOPY AND CONEBEAM CT ON (B)(6) 2016. THE SIDEPORT WAS ACCESSED UNDER STERILE PROCEDURE AND THERE WAS DIFFICULTY WITHDRAWING FORM SIDE PORT (PREVIOUS SIDE PORT ASPIRATION AT UC WAS DESCRIBED AS NORMAL FLOW), BUT WERE ABLE TO CLEAR 0.4ML OF FLUID INTO SYRINGE WHICH WOULD CLEAR CATHETER OF ITB (CATHETER VOLUME 0.251ML). CONTRAST WAS THEN SLOWLY INFUSED AND FLOW OBSERVED UNDER FLUOROSCOPY AND NO ABNORMAL COLLECTIONS OF CONTRAST WERE SEEN ALONG ROUTE OF CATHETER WITH CONTRAST CLEARLY LEAVING CATHETER NEAR TIP (WHICH IS LOCATED AT C7). CONE BEAM CT WAS THEN DONE AFTER FURTHER CONTRAST INJECTION WITH ABNORMAL ACCUMULATION OF CONTRAST ALONG LEFT SIDE OF SPINAL CANAL (DID NOT POOL POSTERIORLY AS EXPECTED WITH PATIENT IN SUPINE POSITION). THEREFORE IT WAS FELT THE ITB WAS NOT DIFFUSING THROUGHOUT SPINAL COLUMN AS WOULD BE IN NORMAL STATE. THE PATIENT WAS OBSERVED FOR 2 HOURS FOLLOWING INITIAL CONTRAST INFUSION IN CASE NOT ALL OF ITB WAS CLEARED FROM THE CATHETER. THE PATIENT DID WELL DURING THIS TIME AND SHOWED NO SIGNS OF ITB OVERDOSE. THE PATIENT WAS DISCHARGED HOME. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING AN UNKNOWN DRUG VIA AN IMPLANTABLE PUMP. THE INDICATIONS FOR USE WERE INTRACTABLE SPASTICITY AND SPINAL CORD INJURY/SPINAL CORD DISEASE. IT WAS REPORTED THE CATHETER WAS SCHEDULED TO BE REVISED ON (B)(6) 2017. IT WAS UNKNOWN WHAT FACTORS MAY HAVE LED TO THE EVENT. THE ISSUE WAS NOT RESOLVED AND THE PATIENT STATUS WAS NOTED AS ALIVE, NO INJURY. ON (B)(6) 2017 ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD A LOCULUS/LOCULAI AT THE TIP OF THE CATHETER THEREBY PREVENTING NORMAL FLOW OF DRUG. THE PHYSICIAN REMOVED PART OF THE SPINAL SEGMENT AND ADDED A NEW SPINAL SEGMENT TO THE PATIENT¿S EXISTING CATHETER. A DYE STUDY WAS PERFORMED INTRA-OPERATIVELY AND ASPIRATED SUCCESSFULLY. THE BACLOFEN DOSE WAS STARTED AT A RATE OF 25% LESS THAN BEFORE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON 2017-FEB-02 FROM A MANUFACTURER REPRESENTATIVE REPORTED A HEALTHCARE PROFESSIONAL (HCP) REPORTED THE EVENT TO THEM, BUT WAS NOT SURE WHICH HCP. REP WAS NOT AWARE OF ANY SYMPTOMS EXPERIENCED. IT WAS NOTED THAT THE REP WILL FOLLOW UP WITH HCP FOR WHEN THE PATIENT FIRST STARTED EXPERIENCING THE NEED FOR A CATHETER REVISION AND WHAT TROUBLESHOOTING WAS PERFORMED RELATED TO THE NEED FOR A CATHETER REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74465 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169100824

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention