BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 2690806 · Received August 10, 2012

    Report

    Report Number
    3004209178-2012-06761
    Event Type
    Death
    Date Received
    August 10, 2012
    Report Date
    July 16, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8596SC, LOT# SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYPE CATHETER. (B)(4). ANALYSIS OF THE PUMP FOUND NO ANOMALY. THE PUMP PASSED ALL NON-DESTRUCTIVE TESTING. ANALYSIS OF THE CATHETER FOUND NO SIGNIFICANT ANOMALY. THERE WAS ACCEPTABLE TESTING. THE CATHETER WAS INCOMPLETE AND RETURNED IN SEG MENTS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CONFIRMED THE PATIENT¿S DEATH WAS NOT RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED PNEUMONIA POST-OPERATIVELY AND WAS TAKEN TO THE INTENSIVE CARE UNIT (ICU). HE WAS PLACED ON CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) MACHINE AND APPEARED TO BE DOING "OK" FOR A WHILE BUT LATER HE WAS PLACED ON RESPIRATORY SUPPORT. THE PATIENT'S FAMILY CHOSE TO WITHDRAW CARE BECAUSE HE WAS TERMINAL AND THE PATIENT QUICKLY PASSED AWAY. THE HEALTH CARE PROVIDER (HCP) INDICATED THAT THE CAUSE OF DEATH WAS UNRELATED TO THE DEVICE AND IT JUST WAS A MEDICAL COMPLICATION FOR THE PATIENT. THE DRUG DELIVERED VIA PUMP WAS LIORESAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death