BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3915707 · Received July 7, 2014

    Report

    Report Number
    3004209178-2014-12581
    Event Type
    Injury
    Date Received
    July 7, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    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

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, LOT # N302515005, IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, LOT # H843519806, IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8598A, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, LOT # H843519806, IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID NEU_UNKNOWN_CATH, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    A CATHETER PROBLEM WAS REPORTED. THE PATIENT¿S PHYSICIAN WAS GOING TO DO A CATHETER REVISION. IT WAS NOTED THAT THEY HAD BEEN INCREASING THE PATIENT¿S DOSE AND HAD DONE THAT A NUMBER OF TIMES, BUT IT WAS NOT HELPING THE PATIENT ANYMORE. THE PHYSICIAN DID ¿SOME SORT¿ OF TEST THE WEEK PRIOR TO DETERMINE THAT THE CATHETER APPARENTLY NEEDED TO BE SPLICED WHICH THEY WERE GOING TO DO THE DAY OF REPORT. THE PUMP WAS USED TO INFUSE BACLOFEN. IT WAS REPORTED LATER THE SAME DAY THAT THE PATIENT HAD A CHANGE IN THERAPY EFFECT. IT WAS NOTED THAT THERE WAS A SEPARATION IN CATHETER IDENTIFIED UNDER IMAGING. DURING A CATHETER REPLACEMENT THE PUMP SEGMENT WAS TIED OFF AND THEY WERE NOT ABLE TO GET SPINAL FLUID. THE PATIENT¿S HEALTH CARE PROFESSIONAL (HCP) WANTED TO SET THE PUMP TO MINIMUM RATE AND LEAVE THE PUMP SEGMENT IN AND CAP IT OFF. IT WAS REPORTED THAT THEY WOULD GO BACK IN A FEW DAYS LATER AND REVISE IT AGAIN, ON MONDAY, WHEN THE PATIENT HAS BUILT UP MORE SPINAL FLUID. THE PATIENT¿S HCP WAS GOING TO SUPPLEMENT THE PATIENT WITH ORAL MEDICATION. IT WAS NOTED THAT THE WEEK PRIOR THE HCP SAW A SEPARATION IN THE CATHETER VIA X-RAY OR MRI. IT WAS LATER REPORTED THAT THE PATIENT HAD AN MRI WHICH REVEALED A CATHETER BREAK NEAR ANCHOR. THE PATIENT¿S HEALTH CARE PROFESSIONAL (HCP) USED A SPLICER KIT TO CONNECT THE TWO PIECES, ONCE CONNECTED THE HCP ATTEMPTED TO ASPIRATE THE CATHETER THROUGH THE CAP BUT WAS UNSUCCESSFUL. THE HCP DISCONNECTED THE PIECES AND WAS ABLE TO ASPIRATE THE CATHETER CONNECTED TO THE PUMP AND DECIDED TO REPLACE THE SPINAL SEGMENT. IT WAS NOTED THAT AFTER MANY ATTEMPTS TO PLACE TOUGHY NEEDLE IN INTRATHECAL SPACE AND NO CSF OBSERVED THE HCP DECIDED TO TIE OFF CATHETER AND REPLACE ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT REMAINS IN THE HOSPITAL. IT WAS NOTED 45.6 CM OF CATHETER CONNECTED TO THE PUMP REMAINS IN THE PATIENT. THE PATIENT DAILY DOSE WAS DECREASED FOLLOWING THE PATIENT¿S REPLACEMENT. IT WAS REPORTED THAT THE PATIENT HAD TROUBLE GETTING INTO THE INTRATHECAL SPACE AND DECIDED TO STOP THE PROCEDURE. IT WAS NOTED THAT THE PATIENT¿S HEALTH CARE PROFESSIONAL DECIDED ON (B)(6) 2014 TO REVISE. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT CATHETER WAS EXPLANTED (B)(6) 2014. IT WAS NOTED THAT THE PATIENT HAD A CATHETER BREAK WITH A DATE OF (B)(6) 2014 PROVIDED. IT WAS REPORTED THAT THE PATIENT HAD INCREASED SPASTICITY, ¿LE¿. IT WAS NOTED THAT THE CATHETER ISSUE WAS A BREAK, TEAR AND DISLODGMENT/MIGRATION. THE LOCATION OF THE CATHETER ISSUE WAS THE DISTAL (SPINAL) SEGMENT. THE CATHETER ISSUE WAS IDENTIFIED ON (B)(6) 2014 USING X-RAY. IT WAS REPORTED THAT SURGICAL INTERVENTION OCCURRED IN (B)(6) 2014. THE TYPE OF INTERVENTION WAS SPECIFIED AS A REVISION AND NO CATHETER OR CATHETER SEGMENTS WERE LEFT IN THE PATIENT, NOT IN USE. IT WAS REPORTED THAT THERE WERE NO CATHETER SEGMENTS LEFT IN THE INTRATHECAL SPACE. THERE WAS A LEAKAGE OF SPINAL FLUID WHEN THE CATHETER WAS EXPLANTED. IT WAS ALSO NOT THAT THERE WAS A 2-STAGE SURGERY, AND THE HEALTH CARE PROFESSIONAL (HCP) REPAIRED A DURAL DEFECT. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. THE TYPE OF BACLOFEN CONTAINED IN THE PUMP WAS LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393956 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00012 YR Hospitalization| R