BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5963774 · Received September 20, 2016

    Report

    Report Number
    3004209178-2016-19274
    Event Type
    Injury
    Date Received
    September 20, 2016
    Date of Event
    May 5, 2016
    Report Date
    October 28, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, PRODUCT TYPE: CATHETER.

    Additional Manufacturer Narrative · 1

    (B)(4) NO LONGER APPLIES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT RECEIVING INTRATHECAL BACLOFEN AND DILAUDID (CONCENTRATIONS AND DOSES UNKNOWN) VIA AN IMPLANTED PUMP FOR INTRACTABLE SPASTICITY. THE PATIENT HAD A HISTORY OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) AND CHRONIC INTRACTABLE PAIN. THE PATIENT EXPERIENCED SOME INCREASED PAIN ALONG WITH SOME HEADACHES. SHE HAS HAD SOME LEAKAGE OF CEREBROSPINAL FLUID (CSF) AROUND THE CATHETER ENTRY SITE. THE PLAN AT THIS TIME WAS ¿WOUND EXPLORATION AND REMOVAL OF PREVIOUS CATHETER AND REVISION OF INTRATHECAL PAIN PUMP CATHETER¿. AN OPERATIVE REPORT STATED THAT THERE WAS A ¿PAIN PUMP CATHETER MALFUNCTION¿. THE EXISTING CATHETER WAS PARTIALLY REMOVED AND THE PHYSICIAN DID A REVISION CONNECTING THE NEW CATHETER TO THE REMAINDER OF THE EXISTING. ON (B)(6) 2016 THE HEALTHCARE PROVIDER (HCP) NOTICED FLUID COLLECTION. DIAGNOSTICS PERFORMED RELATED TO THE CEREBROSPINAL FLUID (CSF) LEAK AND SEROMA INCLUDED A ¿FLUID TAP¿ ON (B)(6) 2016, A REFILL ON (B)(6) 2016, LABS ON (B)(6) 2016, CHEST X-RAY (CXR), CARDIOKYMOGRAPHY (CKG), (B)(6) 2016 OPERATING ROOM (OR) AND (B)(6) 2016 ¿ADMIT¿. IT WAS UNKNOWN WHAT THE CAUSE OF THE CEREBROSPINAL FLUID (CSF) LEAK AND SEROMA WAS. PER THE OPERATIVE REPORT PROVIDED, THE PATIENT WAS TAKEN TO THE OPERATING ROOM ON (B)(6) 2016 AND AFTER CUTTING THROUGH THE SKIN AND SUBCUTANEOUS TISSUE THE SUBCUTANEOUS CSF SEROMA WAS ENCOUNTERED AND A SAMPLE WAS SENT FOR CULTURES. THE RETRACTOR WAS PLACED FOR EXPOSURE. THE PREVIOUS ANCHOR WAS DETACHED AND REMOVED. THERE WAS SOME LEAKAGE AROUND THE CATHETER SITE. THE HCP WENT AHEAD AND PUT A FIGURE OF EIGHT 0 NUROLON DRAIN AROUND THE CATHETER, PULLED THE CATHETER OUT AND REAPPROXIMATED THE EXIT SITE. A SECOND SUTURE WAS PLACED AND A WATERTIGHT CLOSURE WAS ACHIEVED. THE REST OF THE AREA WAS INSPECTED AND THERE WAS SOME AREA OF LOOSENING OF THE FASCIA AND THE HCP WENT AHEAD AND PUT 0 NUROLON SUTURE X2 AROUND THAT AND SECURED IT WITH VALSALVA MANEUVER, NO FURTHER LEAKAGE WAS SEEN. A NEW ENTRY POINT WAS CHOSEN AT L3-L4 LEVEL AT A 14-GAUGE TUOHY NEEDLE REVIEW WAS USED TO ACCESS LUMBAR STENOSIS ON THE FLUOROSCOPY. THE NEW CATHETER WAS THREADED T TO THE T8-T9 AREA AND THE NEEDLE AND STYLET WERE REMOVED PRIOR TO REMOVAL. A #8 NUROLON SUTURE WAS PUT AROUND THE ENTRY POINT AND THEN SECURED AROUND THE CATHETER TO BRING THE FASCIA CLOSED OVER THE CATHETER. THERE WAS A GOOD FLOW OF CSF DISTALLY AND THE EXCESS CATHETER WAS TRIMMED OFF USING THE SUTURELESS CONNECTIONS SYSTEM. THE NEW CATHETER WAS HOOKED UP TO THE OLD CATHETER THAT WAS GOING AROUND THE FLANK TO THE PUMP. THIS WAS THE SPLICING SEGMENT WAS THEN PLACED INTO THE FASCIA AND SECURED USING 0 NUROLON SUTURE. ¿CARE WAS TAKEN TO MAKE SHOULDER CATHETER WAS NOT KINKED AND LOOSE AND CALLED AND SUBCUTANEOUS TISSUE¿. THE WOUND WAS THEN IRRIGATED WITH SALINE AND BACITRACIN, REAPPROXIMATED WITH 2-0 VICRYL IN INVERTED FASHION FOR THE SUBCUTANEOUS TISSUE AND 3-0 NYLON IN RUNNING LOCKED FASHION FOR SKIN. STERILE DRESSING WAS APPLIED. THE PATIENT PUMP WAS THEN PROGRAMMED TO REFILL THE ANESTHETIC. THE SEGMENT CATHETER WAS PLACED AND TELEMETRY WAS ENGAGED. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION POST-EXTUBATION. THE ESTIMATED BLOOD LOSS WAS MINIMAL. THE PAIN AND HEADACHES HAVE BEEN RESOLVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP). THE STATEMENT PAIN PUMP CATHETER MALFUNCTION WAS CLARIFIED TO MEAN LEAKAGE AROUND CATHETER SITE. NO CULTURES OF THE CSF SEROMA WERE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614389 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R