BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3120578 · Received May 20, 2013

    Report

    Report Number
    3007566237-2013-01676
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8711, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 1999, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ROUTINE PUMP REPLACEMENT WAS BEING PERFORMED AS IT HAD REACHED ITS ELECTIVE REPLACEMENT INDICATION. THE PUMP POCKET WAS OPENED AND SIGNIFICANT QUANTITIES OF WHAT APPEARED TO BE CLOTTING BLOOD WAS SEEN. IT WAS FOUND THAT THE CATHETER HAD PREVIOUSLY FRACTURED AND HAD BEEN ¿REPAIRED¿ BY A PRIOR SURGEON BY TYING THE FRACTURED COMPONENT BACK TOGETHER WITH NON-ABSORBABLE SUTURES. THE ¿REPAIR¿ HAD BROKEN AND THE PROXIMAL END OF THE CATHETER HAD BEEN OCCLUDED BY A BROWN CLOTTED MATERIAL WHICH WAS SPECULATED TO BE BLOOD. THE CURRENT SURGEON TRIMMED THE PROXIMAL END OF THE CATHETER, FLUSHED IT WITH PEROXIDE SOLUTION AND SALINE, AND ASPIRATED WHAT SHE HAD HOPED WAS CEREBROSPINAL FLUID. THE PROXIMAL END OF THE CATHETER WAS THEN REPLACED USING A CATHETER KIT AND THE SURGERY WAS COMPLETED. SUBSEQUENTLY, IT WAS FOUND THAT THE PATIENT HAD ¿SPASMING¿ FOR AT LEAST THE PRIOR TWELVE MONTHS. IT WAS ALSO NOTED THAT THE PATIENT HAD BEEN HAVING ¿GASTRO-INTESTINAL ISSUES¿ CONCURRENTLY WITH THE SPASMS. A HEALTHCARE PROVIDER (HCP) STATED THAT IT WAS FELT THAT THE INCREASED SPASMS WERE PROBABLY DUE TO THE INTESTINAL ISSUES AND SURGERIES. THERE WERE INCREASED SPASMS IN THE PATIENT¿S LEGS, THOUGH THEY WERE REPORTEDLY NOT SEVERE OR SIGNIFICANT ENOUGH THAT THE HCPS WOULD SUSPECT THAT THE PATIENT HAD NOT BEEN RECEIVING BACLOFEN THROUGH THE DEVICE. ADDITIONALLY, THE PATIENT HAD INCREASED SPASTICITY. THE PLAN WAS TO RESTART THE PATIENT ON A LOW DOSE OF INTRATHECAL BACLOFEN AS IF THE PATIENT WAS BACLOFEN NAÏVE. THE PATIENT WOULD BE OBSERVED FOR A MINIMUM OF FIVE DAYS FOR POTENTIAL OVERDOSE AND POST-SURGICAL INFECTIONS. THE DEVICE WAS DELIVERING COMPOUNDED BACLOFEN. ABOUT TWO WEEKS LATER, IT WAS REPORTED THAT THE INITIAL CATHETER FRACTURE WITH PARTIAL DISCONNECT FROM THE PUMP HAD OCCURRED SOMETIME BETWEEN 2006 AND (B)(6) 2013. THE FRACTURE WAS LOCATED AT THE PUMP AND CATHETER CONNECTION POINT AND THE CATHETER FIXATION WAS CHECKED AND REVISED AT THE REPLACEMENT. IT WAS STATED THAT, BASED ON THE PATIENT¿S INCREASED SPASTICITY, IT HAD MOST LIKELY OCCURRED IN THE 12-18 MONTHS PRIOR TO REPORT. THE REPORTER FELT THAT IT WAS MOST LIKELY THAT THE CATHETER HAD BEEN INCORRECTLY SUTURED ONTO THE PUMP AT THE REVISION IN 2006, WHEN THE PRIOR PUMP HAD REACHED END-OF-SERVICE. THERE WAS NO KNOWN FALL OR ISSUE THAT LED TO THE ¿SUDDEN POSTURE CHANGE¿. ADDITIONALLY, THERE WAS NO KNOWN WEIGHT GAIN. IT WAS ALSO NOTED THAT DUE TO THE PATIENT¿S SPINAL INJURY, THE LOWER TORSO WAS NOT MOBILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221363 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention