BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 5128367 · Received October 5, 2015

    Report

    Report Number
    3004209178-2015-20008
    Event Type
    Malfunction
    Date Received
    October 5, 2015
    Date of Event
    September 9, 2015
    Report Date
    September 9, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED PUMP EXTERIOR/SUTURE LOOP ANOMALY AND WAS MISSING AND/OR BROKEN IN VIVO.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, LOT# N189565008, IMPLANTED: (B)(6) 2009, 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

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING GABLOFEN (2000, 369/DAY) VIA AN IMPLANTABLE INFUSION PUMP. INDICATIONS FOR USE INCLUDED INTRACTABLE SPASTICITY, AND OTHER SPASTICITY. IT WAS REPORTED THAT UPON OPENING THE PATIENT'S POCKET FOR A PUMP BATTERY CHANGE REPLACEMENT SURGERY, THE HCP NOTICED A SUTURE LOOP AT THE 8 O'CLOCK LOCATION THAT WAS SEPARATED AND SITTING IN THE POCKET. THIS WAS PRIOR TO ANY MANIPULATION OF THE PUMP, AND THE REMAINING SUTURE LOOPS BROKE WHILE REMOVING THE PUMP FROM THE POCKET. IT WAS NOTED THE PUMP WAS IMPLANTED IN THE PATIENT'S RIGHT ABDOMEN. IT WAS UNKNOWN WHAT LED TO THE EVENT, AND NO INTERVENTIONS/ACTIONS WERE TAKEN. THE ISSUE WAS RESOLVED. THE PATIENT STATUS WAS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659239 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00009 YR