BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4337887 · Received December 17, 2014

    Report

    Report Number
    3004209178-2014-24153
    Event Type
    Malfunction
    Date Received
    December 17, 2014
    Date of Event
    May 23, 2014
    Report Date
    November 19, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS SEEN ON THE PUMP LOG THAT THERE WERE MULTIPLE MOTOR STALL AND MOTOR STALL RECOVERIES THAT HAD OCCURRED. MOTOR STALL OCCURRED ON (B)(6)2014 AT 09:30 WITH RECOVERY ON (B)(6) 2014 AT 09:55. MOTOR STALL OCCURRED ON (B)(6) 2014 AT 09:47 WITH RECOVERY ON (B)(6) 2014 AT 10:17. MOTOR STALL OCCURRED ON (B)(6) 2014 AT 09:56 WITH RECOVERY ON (B)(6) 2014 AT 10:51. NO SYMPTOMS WERE REPORTED. (THIS SOURCE DOCUMENT CONTAINED OMITTED INFORMATION, UNRELATED TO THIS EVENT, WHICH IS CAPTURED IN (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828944 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR