BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 6131475 · Received November 29, 2016

    Report

    Report Number
    3004209178-2016-24793
    Event Type
    Death
    Date Received
    November 29, 2016
    Date of Event
    November 11, 2015
    Report Date
    December 21, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION D INFORMATION REFERENCED THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 8709SC. LOT#. SERIAL# (B)(4). IMPLANTED: 2012 (B)(6). EXPLANTED: PRODUCT TYPE CATHETER H3-. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE DEVICE SYSTEM; THE OTHER RELEVANT COMPONENTS INCLUDE: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012 PRODUCT TYPE: CATHETER. PRODUCT ID: NEU_UNKNOWN_CATH, PRODUCT TYPE: CATHETER. ANALYSIS OF THE PUMP IDENTIFIED NO ANOMALIES. (B)(4).

    Description of Event or Problem · 1

    ON 2016 (B)(6) THE PUMP WAS RETURNED AND THE RETURN PAPERWORK NOTED THAT THE PATIENT HAD DIED ON 2015 (B)(6) . THE CAUSE OF DEATH WAS NOT DETERMINED. HOWEVER IT WAS REPORTED THAT THE PRIMARY CAUSE WAS MIXED DRUG INTOXICATION AND THE SECONDARY CAUSE WAS OBESITY. THE PUMP WAS USED TO DELIVER AN UNKNOWN DRUG AND THE INDICATION FOR USE WAS NON-MALIGNANT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783236 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death