BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3965213 · Received July 29, 2014

    Report

    Report Number
    3004209178-2014-13643
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER; PRODUCT ID 8 590-1, LOT# N185023, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A CATHETER BLOCKAGE THREE MONTHS AGO. A REVISION WAS RECOMMENDED AND WAS SCHEDULED 2-3 WEEKS AGO. DURING THE REVISION 2-3 WEEKS AGO THE PATIENT RECEIVED TOO MUCH ANESTHESIA AND HIS HEART STOPPED. THE REVISION DID NOT TAKE PLACE. THE PUMP WAS ALSO GOING TO BE REPLACED DURING THE REVISION DUE TO THE PUMP AGE. THERE WERE NO ALLEGATIONS ABOUT THE PUMP. A SURGERY WOULD NOT BE RESCHEDULED UNTIL THE PATIENT HAD A STRESS TEST. THE PATIENT COULD NOT WALK (WHICH WAS UNDERSTOOD TO BE A PREVIOUS CONDITION). THE PATIENT WAS GOING TO HAVE A NUCLEAR STRESS TEST RATHER THAN A WALKING ONE. THE SURGERY STALLED BECAUSE OF THIS. IT WAS LATER REPORTED THE PATIENT HAD TO BE CLEARED BY CARDIOLOGY PRIOR TO RESCHEDULING THE SURGERY. THE PATIENT HAD CARDIAC FAILURE AFTER INTUBATION AT THE PREVIOUS SURGERY. THE SYSTEM WAS BEING USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441848 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Life Threatening| R