BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3130652 · Received May 24, 2013

    Report

    Report Number
    3004209178-2013-08204
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    May 1, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8703W, LOT # N22135A, IMPLANTED: (B)(6) 1995, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 THAT, AT THE PATIENT¿S LAST REFILL, THE ACTUAL RESIDUAL VOLUME (28 ML) EXCEEDED THE EXPECTED RESIDUAL VOLUME (8 ML). THE PATIENT REPORTED HAVING GONE THROUGH INTERMITTENT WITHDRAWALS. THIS WAS NOTED TO BE OUT OF SPECIFICATION. THE PATIENT¿S PHYSICIAN DECIDED TO REPLACE THE PUMP DUE TO THE AGE OF THE PUMP. THE PATIENT¿S SYMPTOMS INCLUDED UNDERDOSE SYMPTOMS AND LESS THAN 50% THERAPY RELIEF. NO ALARMS WERE NOTED IN THE LOGS. THE MEDICATIONS USED WITHIN THE SYSTEM WERE MORPHINE, CLONIDINE, AND BUPIVACAINE.

    Description of Event or Problem · 1

    THE REPRESENTATIVE LATER REPORTED THE PATIENT HAD WITHDRAWAL SYMPTOMS SINCE (B)(6) 2012. THEY ALSO REPORTED FLU-LIKE SYMPTOMS, AND HAD ¿NO PAIN RELIEF SINCE THAT TIME.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231601 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention