BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2925754 · Received January 22, 2013

    Report

    Report Number
    3004209178-2013-00849
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    January 3, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO ANOMALY. THE LOGS SHOWED MULTIPLE MOTOR STALLS AND RECOVERIES IN THE LOGS. ANALYSIS OF THE CATHETER REVEALED A NON-SIGNIFICANT INDENT WAS SEEN DOWN IN THE CUP OF THE SC CONNECTOR.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS EXPLANTED PER SURGEON RECOMMENDATION. THE PATIENT HAD GOTTEN SICK WHILE USING BOTH FENTANYL AND MORPHINE SULFATE SEPARATELY IN THE PUMP. THE PUMP WAS THEN FILLED WITH SALINE. THERE WERE TWO MOTOR STALLS SEEN IN THE PUMP LOGS, BUT BOTH RECOVERED IN LESS THAN TWO HOURS. IT WAS NOTED THAT THE PATIENT RECOVERED FROM THE EVENT WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29270 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention