BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2962763 · Received February 14, 2013

    Report

    Report Number
    3004209178-2013-02685
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 17, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    MULTIPLE MOTOR STALLS WERE REPORTED. THE PUMP WAS NOTED TO HAVE STALLED ON (B)(6) RESTARTED ON THE (B)(6), AND STALLED AGAIN ON THE (B)(6). NO MRI'S AND NO MAGNETIC EXPOSURE WERE NOTED TO HAVE CAUSED THE MOTOR STALL. IT WAS REPORTED THAT THE PATIENT WAS "REALLY SICK; SEVERELY DEPRESSED; FEELING PAIN; COULD HARDLY WALK; COULD NOT GET OUT OF BED; COULD NOT SLEEP; COULD NOT EAT; AND HAD A REALLY BAD, METALLIC TASTE IN HIS MOUTH." THE PUMP WAS NOTED TO HAVE "FAILED." IT WAS NOTED THAT THE PATIENT'S PUMP WAS TO BE REPLACED ON "MONDAY," (B)(6). THE MEDICATION USED WITHIN THE SYSTEM WAS DILAUDID. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS SUBMISSION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT'S WITHDRAWAL SYMPTOMS RESOLVED QUICKLY AND WITHOUT SEQUELA AFTER PUMP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65596 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention