BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2023447 · Received March 8, 2011

    Report

    Report Number
    3004209178-2011-01713
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    January 6, 2011
    Report Date
    February 10, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0591-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT HAD AN MRI. WHEN THE PT CAME IN ON (B)(6) 2011 FOR A PUMP REFILL, THE PUMP SHOWED A MOTOR STALL THAT COINCIDED WITH THE MRI; NO MOTOR STALL RECOVERY WAS NOTED IN THE LOGS. THE PT HAD NO SYMPTOMS AND THERE WAS NO VOLUME DISCREPANCY WHEN THE VOLUMES WERE CHECKED. ADDITIONAL INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT IF ADDITIONAL INFO 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 77 YR CATHETER: MODEL 8709SC, LOT# N178510008| IMPLANTED:| EXPLANTED: