BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3090568 · Received May 2, 2013

    Report

    Report Number
    3004209178-2013-07229
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    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
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO INTERVENTION WAS NEEDED. THERE WERE NO PATIENT SIGNS OR SYMPTOMS, NO PATIENT INJURY, AND THE PATIENT DID NOT REQUIRE HOSPITALIZATION. IT WAS NOTED THAT THE PUMP MOTOR STALL ERROR RECOVERED.

    Description of Event or Problem · 1

    A CONFIRMED MOTOR STALL NOTED IN EVENT LOGS WITH NO MOTOR STALL RECOVERY FOLLOWING AN MRI OF BOTH THE SHOULDERS WAS REPORTED. PER REPORTER WHEN FIRST READ THE PUMP NOTED THE STALL OCCURRED AT 12:16, THEREAFTER THE HCP READ THE PUMPS AT 12:52, 12:58 AND AT 14:29 THERE WAS NO RECOVERY YET IN THE LOGS. IT WAS INDICATED THAT THEY HAD UPDATED THE PUMP TWICE SINCE THEN. PATIENT DID NOT HAVE ANY SYMPTOMS/ ISSUES. DRUG DELIVERED VIA THE DEVICE WAS DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192211 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR