BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1770219 · Received July 21, 2010

    Report

    Report Number
    3004209178-2010-05641
    Event Type
    Injury
    Date Received
    July 21, 2010
    Date of Event
    January 1, 2010
    Report Date
    June 2, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURE EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED A PROGRESSIVE RETURN OF SPASTICITY OVER A SIX MONTHS PERIOD. A DYE STUDY WAS ATTEMPTED AND IT WAS DISCOVERED THAT THE CATHETER WAS NOT PATENT; THE HEALTHCARE PROVIDER WAS UNABLE TO ASPIRATE FROM THE CATHETER ACCESS PORT AND UNABLE TO INJECT DYE. THE HCP MADE THE DECISION TO REPLACE THE ENTIRE SYSTEM DUE TO DECREASED THERAPEUTIC EFFECTS OF THE INTRATHECAL BACLOFEN. UPON EXPLORATION OF THE SYSTEM IN THE OPERATING ROOM, THE CATHETER WAS DISCONNECTED FROM THE PUMP AND THE CATHETER WAS FOUND TO BE OCCLUDED. THE HCP DECIDED TO REPLACE BOTH THE PUMP AND CATHETER ANYWAY AS HE QUESTIONED THE INTEGRITY OF THE PUMP. IT WAS NOTED THAT THERE WERE NO VOLUME DISCREPANCIES. PER THE REPORTER, THE PATIENT RECOVERED WITHOUT SEQUELA. THE PUMP WAS USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention EXPLANTED:| IMPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 8637-20| LOT# NGP340484H| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N186319| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N132491008| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N247607004