BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 7277387 · Received February 16, 2018

    Report

    Report Number
    3004209178-2018-03446
    Event Type
    Injury
    Date Received
    February 16, 2018
    Date of Event
    December 1, 2017
    Report Date
    August 22, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169530119
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE DEVICE SYSTEM; THE OTHER RELEVANT COMPONENTS INCLUDE: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2017, PRODUCT TYPE: CATHETER. 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 CATHETER WAS RETURNED, AND ANALYSIS FOUND THE CATHETER BODY HAS SIGNIFICANT TWISTING THAT MAY HAVE AFFECTED INFUSION. (B)(4). 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

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE DRUG INFUSION PUMP INDICATED FOR NON-MALIGNANT PAIN. THE PUMP FIRST CONTAINED AN UNKNOWN BRAND OF MORPHINE WITH AN UNKNOWN CONCENTRATION AND DOSE AND THEN CONTAINED SALINE [1 ML/ML] AT A DOSE OF 0.0063 ML/DAY. IT WAS REPORTED THERE WAS A VOLUME DISCREPANCY AT A REFILL IN (B)(6) 2017. THE ACTUAL RESERVOIR VOLUME (ARV) WAS 20 ML, AND THE EXPECTED RESERVOIR VOLUME (ERV) WAS 0 ML. THE PUMP CONTAINED MORPHINE AT THAT TIME. THE REPRESENTATIVE STATED THE MEDICATION WAS REMOVED AT THAT TIME, AND THE PUMP WAS FILLED WITH SALINE. THE REPRESENTATIVE STATED THE PUMP WAS ALARMING IN, ON, OR AROUND (B)(6) 2018, AND WHEN THE RESERVOIR WAS ASPIRATION, ALL THE SALINE WAS STILL THERE. THE ARV WAS 20 ML, AND THE ERV WAS 0 ML. THE REPRESENTATIVE MENTIONED THAT THEY WERE THINKING OF REPLACING THE PUMP. REPORTED SYMPTOMS INCLUDED PAIN. THE CHANGE IN THERAPY/SYMPTOMS WAS CONSIDERED SUDDEN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE REPRESENTATIVE REPORTED DURING THE SURGERY, THE CATHETER WAS FOUND TO BE TWISTED AND CUT WHICH WAS THE CAUSE OF THE INABILITY TO ASPIRATE. A CATHETER REVISION WAS COMPLETED, AND THE PUMP WAS NOT REPLACED. THE REPRESENTATIVE STATED THE SEGMENT OF THE CATHETER THAT WAS REMOVED WOULD BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP). THE CATHETER WAS "ALL TANGLED UP" AND KINKED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE EMPTY RESERVOIR ALARM HAD OCCURRED ON 2018 (B)(6). ON 2018 (B)(6), A CATHETER ACCESS PORT (CAP) DYE STUDY WAS ATTEMPTED BUT THE HCP WAS UNABLE TO ASPIRATE ANY FLUID FROM THE CAP. THE PATIENT HAD A CATHETER REVISION ON 2018 (B)(6). THE PUMP LOGS WERE CHECKED AND NO MOTOR STALLS WERE SEEN. THERE WERE NO FURTHER COMPLICATIONS REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121435 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169530119

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention