BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3811390 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-09004
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED GEAR TRAIN ANOMALIES, INCLUDING CORROSION AND/OR WEAR AND/OR LUBRICATION AND A STALL DUE TO SHAFT- BEARING.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A MOTOR STALL CONFIRMED IN THE EVENT LOGS WITH NO RECOVERY RECORDED. IT WAS NOTED THERE WAS ONE MOTORS STALL IN THE EVENTS LOGS AND IT OCCURRED AT 12:22 THE DAY OF REPORT AND HAD NOT RECOVERED BY 3:48. IT WAS NOTED THE PATIENT WAS AT THE CAR SHOP AT THE TIME OF THE STALL, BUT DID NOT RECALL BEING EXPOSED TO A MAGNET. THE PUMP WAS USED TO DELIVER BUPIVACAINE AND MORPHINE. ADDITIONAL INFORMATION REPORTED THE PUMP WAS REPLACED. IT WAS NOTED THE ALARM SOUNDED AND THE MOTOR STALL HAD STILL NEVER RECOVERED. IT WAS STATED THE PATIENT WAS STABILIZED ON ORAL PAIN MEDICATIONS, AND FURTHER WITHDRAWAL WAS ABATED. IT WAS REPORTED THERE WERE UNDERDOSE SYMPTOMS OF NAUSEA, VOMITING AND GENERAL MALAISE AT THE DEVICE POCKET. THE PATIENT STATUS WAS NOTED AS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION REPORTED THE MOTOR STALL OCCURRED AT 11:31 ON (B)(6) 2014. IT WAS REPORTED THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291290 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR Required Intervention