BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2043175 · Received March 25, 2011

    Report

    Report Number
    3004209178-2011-02296
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT HAD A MAGNETIC RESONANCE IMAGING. THE PUMP WAS INTERROGATED AFTERWARD. A PUMP STALL WAS NOTED ON THE EVENT LOGS OF THE PUMP. NO STALL RECOVERY WAS RECORDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 48 YR EXPLANTED:| CATHETER: MODEL 88731SC, LOT# N258001007| IMPLANTED: