BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2624246 · Received June 21, 2012

    Report

    Report Number
    3004209178-2012-04702
    Event Type
    Injury
    Date Received
    June 21, 2012
    Report Date
    May 24, 2012
    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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8709SC, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: 2012 (B)(6); POUCH MODEL: 8590-1, LOT# N201723, IMPLANTED: 2009 (B)(6), EXPLANTED: 2012 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP "FAILED" AND WAS REPLACED. IT WAS STATED THAT PATIENT HAD EXPERIENCED AN INCREASE IN SPASTICITY. AT THE TIME OF PUMP REPLACEMENT HEALTHCARE PROVIDER (HCP) FOUND FLUID IN THE PUMP POCKET. DRUG DELIVERED VIA THE DEVICE WAS COMPOUNDED BACLOFEN 500MCG/ML ,175MCG /DAY. FOLLOWING REPLACEMENT PATIENT WAS PROGRAMMED DOWN TO 24 MCG/DAY DOSE. IT WAS LATER REPORTED THAT A DYE STUDY WAS DONE THAT SHOWED GOOD FLOW AND CATHETER INTACT. THE FLUID WAS TESTED AND IT WAS NEGATIVE FOR GRAM STAIN, UNKNOWN WHAT THE FLUID WAS. THE HOSPITAL DID NOT HAVE THE EXPLANTED PUMP AND REPORTER DID NOT KNOW WHERE IT WAS. IT WAS STATED THAT FOLLOWING REPLACEMENT THE PATIENT RESPONDED POSITIVELY FOR ABOUT SIX WEEKS, AND THEN STARTED HAVING INCREASE IN S PLASTICITY AGAIN (THIS EVENT HAS BEEN REPORTED IN MANUFACTURER REPORT # 3004209178-2012-04701).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention