BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 7581072 · Received June 8, 2018

    Report

    Report Number
    3004209178-2018-12938
    Event Type
    Injury
    Date Received
    June 8, 2018
    Date of Event
    May 27, 2018
    Report Date
    August 16, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169100824
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP ON 2018-AUG-15 REVEALED A PUMP MOTOR GEAR TRAIN ANOMALY REGARDING CORROSION AND/OR WEAR AND/OR LUBRICATION; STALL WAS DUE TO THE SHAFT BEARING. 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 HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING DILAUDID WITH CONCENTRATION 5 MG/ML AT A DOSE RATE OF 1.9980 MG/DAY AND BUPIVACAINE WITH CONCENTRATION 4.5 MG/ML AT A DOSE RATE OF 1.7982 MG/DAY AS OF (B)(6) 2018 VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT A MOTOR STALL OCCURRED. THE EVENT OCCURRED DURING NORMAL USE. AS PER THE PUMP¿S LOG PROVIDED, THE FOLLOWING OCCURRED: (B)(6) 2018 06:12 - MOTOR STALL OCCURRED (B)(6) 2018 20:17 ¿ MOTOR STALL RECOVERY OCCURRED (B)(6) 2018 20:19 ¿ MOTOR STALL OCCURRED (B)(6) 2018 20:19 ¿ STOPPED PUMP PERIOD MAY EXCEED TUBE SET MESSAGE OCCURRED (B)(6) 2018 20:24 ¿ MOTOR STALL RECOVERY OCCURRED (B)(6) 2018 09:14 ¿ MOTOR STALL OCCURRED (B)(6) 2018 11:18 ¿ MOTOR STALL OCCURRED THE PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS. IT WAS INDICATED THAT THERE WAS NO REPORT OF ANY ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. DIAGNOSTIC TESTING/TROUBLESHOOTING PERFORMED INCLUDED INTERROGATION. IT WAS REPORT ED THAT THE PUMP WAS SCHEDULED TO BE REPLACED ON (B)(6) 2018. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. OTHER MEDICATIONS THE PATIENT WAS RECEIVING AT THE TIME OF THE EVENT WAS UNABLE TO BE OBTAINED. THE PATIENT WAS WITH INJURY REGARDING THEIR STATUS AT THE TIME OF THE REPORT. REGARDING DETAILS OF THE INJURY AND PATIENT RECOVERY, NARCOTIC WITHDRAWAL WAS INDICATED. THE PATIENT¿S MEDICAL HISTORY WAS REQUESTED BUT WAS UNAVAILABLE REGARDING A LEGAL/CONFIDENTIAL REASON. AS PER THE MANUFACTURE¿S DEVICE REGISTRY, THE PUMP WAS EXPLANTED AND REPLACED ON (B)(6) 2018. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED VIA A COMPANY REPRESENTATIVE. IT WAS INDICATED THAT THE PUMP WAS RECEIVED BACK FROM THE HEALTHCARE PROVIDER ON (B)(6) 2018 AND IT WAS BEING RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426027 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169100824

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention