BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5729537 · Received June 16, 2016

    Report

    Report Number
    3004209178-2016-12341
    Event Type
    Injury
    Date Received
    June 16, 2016
    Date of Event
    April 1, 2016
    Report Date
    July 12, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 871153, SERIAL# (B)(4), PRODUCT TYPE: CATHETER. PRODUCT ID 8598A, LOT# 0205546626, PRODUCT TYPE: CATHETER. 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

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_CATH, PRODUCT TYPE :CATHETER. 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

    ON 2016-06-22, ADDITIONAL INFORMATION WAS RECEIVED FROM A FOREIGN MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT A SMALL PORTION OF THE PUMP SEGMENT WAS TRIMMED AND CONNECTED WITH A PIN AND THE CONNECTOR WAS RECONNECTED.

    Description of Event or Problem · 1

    ON 2016-05-25 (B)(4), E1C (REP); ON 2016-05-25, INFORMATION WAS RECEIVED FROM A FOREIGN MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS RECEIVING LIORESAL (1000 MCG/ML; DOSE REPORTED AS 158 MCG/DAY AND 190.2 MCG/DAY) VIA AN IMPLANTABLE PUMP FOR AN UNKNOWN INDICATION FOR USE. IN (B)(6) 2016, THE PATIENT DEVELOPED INCREASED SPASTICITY AND DESPITE DOSING INCREASES, HAS NOT IMPROVED. A CATHETER ACCESS PORT (CAP) DYE STUDY AND COMPUTED TOMOGRAPHY (CT) SCAN WERE PERFORMED AND THEY WERE UNABLE TO SEE ANY DYE. HOWEVER, THEY WERE ABLE TO ASPIRATE FREELY FROM THE CAP. IT WAS NOTED THAT THERE WAS NO DYE BEHIND THE PUMP. THE PUMP LOGS WERE CHECKED AND THERE WERE NO PUMP ALARMS. THE REPRESENTATIVE WAS UNAWARE OF ANY PUMP RESERVOIR VOLUME DISCREPANCIES. THEY WERE CURRENTLY RULING OUT A POSSIBLE URINARY TRACT INFECTION (UTI) AND WERE ALSO QUESTIONING NOXIOUS STIMULI (WOUNDS TO FEET AND BUTTOCKS). ADDITIONAL INFORMATION RECEIVED ON 2016-06-14 REPORTED THE PATIENT WAS BROUGHT INTO THE OPERATING ROOM THE FOLLOWING WEEK AND THE HEALTHCARE PROFESSIONAL (HCP) DISCOVERED THE SEGMENT OF THE PUMP CONNECTOR WAS TORN. POST SURGERY, THE PATIENT STAYED OVERNIGHT AND TITRATION WAS PERFORMED. THERE WERE NO FURTHER COMPLAINTS FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383688 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention