BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2930003 · Received January 25, 2013

    Report

    Report Number
    3004209178-2013-00980
    Event Type
    Injury
    Date Received
    January 25, 2013
    Report Date
    January 8, 2013
    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
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO ANOMALIES. THE PUMP'S ERI WAS DUE IN LESS THAN A MONTH AS OF THE DATE OF THIS REPORT. AT THE TIME OF EXPLANT, THE ESTIMATED ERI WAS APPROXIMATELY TWO MONTHS. THE PUMP PASSED DISPENSE ACCURACY TESTING. ANALYSIS OF THE CATHETER REVEALED A HOLE IN THE CATHETER BODY CAUSED BY THE METAL PIN OF THE PUMP CONNECTOR.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP WAS DYSFUNCTIONAL AFTER 'ALMOST SEVEN YEARS' OF PERFORMING. IT WAS NOTED THE PATIENT HAD AN INCREASE OF SPASTICITY. IT WAS REPORTED THE 'THE PUMP IS EXPLANTED WHEN IT WAS TIME TO CHANGE FOR A NEW ONE.' THE DEVICE SYSTEM WAS BEING USED TO DELIVER LIORESAL. IT WAS LATER REPORTED THE PUMP HAD ITS ELECTIVE REPLACEMENT INDICATOR WHEN EXPLANTED. THERE WERE NO MESSAGES NOTICED AT THE INTERROGATION TO INDICATE PUMP MALFUNCTION. IT WAS NOTED THE HEALTH CARE PROVIDER HAD COMPLAINED THE PUMP WAS NOT WORKING PROPERLY. A DYE TEST WAS PERFORMED AND IT WAS REPORTED EVERYTHING SEEMED OKAY WITH THE CATHETER. THE PATIENT'S STATUS WAS PROVIDED AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36060 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00017 YR Required Intervention