BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 13508334 · Received February 10, 2022

    Report

    Report Number
    3004209178-2022-01867
    Event Type
    Injury
    Date Received
    February 10, 2022
    Report Date
    February 10, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169508156
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010 PRODUCT TYPE: CATHETER. PRODUCT ID: 8578 SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER, OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8709SC, SERIAL/LOT #: (B)(4), (B)(6) 2012, UBD: 11-MAR-2012, UDI#: (B)(4) ; PRODUCT ID: 8578, SERIAL/LOT #: UNKNOWN, UBD: 11-MAR-2012. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS RECEIV ING PRIALT AND MORPHINE VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING AN INCREASE IN PAIN AND VOLUME DISCREPANCIES. THERE WERE NO KNOWN EXTERNAL FACTORS THAT CONTRIBUTED TO THE EVENT. DIAGNOSTICS/TROUBLE SHOOTING INCLUDED PERFORMING A SIDE PORT ASPIRATION OF THE CATHETER BUT IT WAS UNSUCCESSFUL. SURGERY IS SCHEDULED FOR (B)(6) 2022 TO REPLACE BOTH THE PUMP AND CATHETER. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION RECEIVED FROM THE COMPANY REPRESENTATIVE INDICATED THAT THE DISTAL PORTION OF THE 8709 WAS FOUND TO BE IN PLACE AND PATENT. THEREFORE, AN 8596SC WAS ADDED AND DOSING WAS DROPPED TO 1 MCG/DAY. THE CATHETER WAS FOUND TO BE COILED MULTIPLE TIMES IN THE POCKET, THE PUMP WAS FLIPPED, AND THE 8578 PUMP SEGMENT WAS CLOGGED. ONCE THE MAJORITY OF THE PROXIMAL PUMP SEGMENT WAS REMOVED, IT WAS DETERMINED THAT THE SPINAL SEGMENT WAS STILL INTRATHECAL. ADDITIONAL INFORMATION RECEIVED FROM THE COMPANY REPRESENTATIVE INDICATED THAT THE SERIAL NUMBER OF THE 8578 PUMP SEGMENT WAS UNKNOWN. THE EXPECTED RESERVOIR VOLUME VERSUS THE ACTUAL RESERVOIR VOLUME FILLED AT LAST REFILL WAS UNKNOWN; AT THE PATIENT'S REVISION/REPLACEMENT ON (B)(6) 2022, THERE WAS NO DISCREPANCY. TO RESOLVE THE COILED CATHETER/CLOGGED PUMP SEGMENT AND FLIPPED PUMP, THE PUMP WAS REPLACED AND THE CATHETER WAS UNCOILED AND REPLACED WITH AN 8596SC WHICH ALSO REPLACED THE 8578 CL OGGED SEGMENT. THE EVENT WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1844275 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169508156

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention