BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 6341008 · Received February 17, 2017

    Report

    Report Number
    3004209178-2017-04115
    Event Type
    Malfunction
    Date Received
    February 17, 2017
    Report Date
    February 17, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169508156
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: CATHETER. INTERROGATION OF THE PUMP DETERMINED IT WAS USED TO INFUSE MORPHINE [18.9 MG/ML] AT 12.079 MG/DAY; BUPIVACAINE [9.5 MG/ML] AT 6.0716 MG/DAY; AND FENTANYL [2000 MCG/ML] AT 1,278.2 MCG/DAY. ANALYSIS OF THE CATHETER FOUND TEARS/CORING IN THE CUP OF THE SUTURELESS CONNECTOR (SC). DURING PRESSURE TESTING, THE CATHETER MET LEAK CRITERIA PER NDHF 1162-113599. (B)(4). 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.

    Description of Event or Problem · 1

    INFORMATION WAS PROVIDED BY A MEDICAL EXAMINER REGARDING AN IMPLANTABLE INTRATHECAL PUMP INTENDED TO DELIVER AN UNKNOWN DRUG, INDICATED FOR NON-MALIGNANT PAIN. THE PUMP AND CATHETER WERE RETURNED TO THE MANUFACTURER FOR ROUTINE ANALYSIS WITHOUT ANY KNOWN COMPLAINTS. THE DOCUMENTATION RECEIVED WITH THE DEVICES INDICATED THAT THE PATIENT WAS DECEASED. PER THE MEDICAL EXAMINER, THE PATIENT PASSED AWAY ON (B)(6) 2016, AND THE CAUSE OF DEATH WAS HYPERTENSIVE CARDIOVASCULAR DISEASE (HCVD). THERE WAS NO ALLEGATION OR INFORMATION THAT REASONABLY SUGGESTED THAT THE PATIENT¿S INFUSION SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT¿S DEATH. IT WAS NOTED THAT THE PATIENT'S MEDICAL HISTORY INCLUDED CHRONIC PANCREATITIS AND THE PATIENT HAD BEEN ON LONG-TERM OPIATE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121593 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169508156

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR