BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2439680 · Received February 6, 2012

    Report

    Report Number
    3004209178-2012-00795
    Event Type
    Malfunction
    Date Received
    February 6, 2012
    Date of Event
    January 18, 2012
    Report Date
    January 18, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z# 0591-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER: MODEL: 8731SC, SERIAL #: (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: UNK; CATHETER POUCH: MODEL: 8590-1, LOT #: N230604, IMPLANTED: (B)(6) 2009, EXPLANTED: UNK; PROGRAMMER: MODEL: 8835, SERIAL #: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CONFIRMED MOTOR STALL NOTED IN EVENT LOGS WITH NO MOTOR STALL RECOVERY WAS REPORTED. MOTOR STALL WAS CAUSED BY PATIENT HAVING MRI OR OTHER MEDICAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR