BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 9311699 · Received November 12, 2019

    Report

    Report Number
    3004209178-2019-21621
    Event Type
    Injury
    Date Received
    November 12, 2019
    Date of Event
    October 4, 2019
    Report Date
    February 10, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169100824
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED, AND ANALYSIS FOUND CORROSION AND-OR WEAR AND-OR LUBRICATION AND STALL DUE TO SHAFT BEARING. ALL PREVIOUSLY REPORTED METHOD, RESULT, AND CONCLUSION CODES NO LONGER APPLY TO THIS EVENT. 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 CONSUMER VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING GABLOFEN 2000 MCG/ML FOR A TOTAL DOSE OF 2145 MCG/DAY VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY AND OTHER SPASTICITY. IT WAS REPORTED THE PATIENT'S CAREGIVER NOTED AN ALARM AND CALLED PARENTS OF PATIENT ON (B)(6) 2019. THE PARENTS NOTIFIED THE HEALTHCARE PROFESSIONAL (HCP) OFFICE AND WERE INFORMED TO BRING THE PATIENT TO THE HOSPITAL. THE PATIENT WAS PLACED IN THE INTENSIVE CARE UNIT (ICU). IT WAS NOTED THE PATIENT HAS NOT BEEN FEELING WELL WITH FEVERS AND FLU LIKE SYMPTOMS OVER THE LAST MONTH. THERE WAS NO FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE PUMP WAS INTERROGATED UPON ARRIVAL TO THE HOSPITAL AND NOTED THAT THE MOTOR STALLED. THE REP INTERROGATED THE PUMP ON (B)(6) 2019 AND NOTED IN THE LOGS THAT THE PUMP HAS STALLED SEVERAL TIMES SINCE (B)(6) 2019. THE LOGS INDICATED THE MOTOR STALL ON (B)(6) 2019 AT 6:18AM WITH A RECOVERY ON (B)(6) 2019 AT 10:41PM, STALLED ON (B)(6) 2019 AT 7:49AM WITH A RECOVERY ON (B)(6) 2019 AT 3:24PM, STALLED ON (B)(6) 2019 AT 8:28PM WITH A RECOVERY ON (B)(6) 2019 AT 4:17AM, STALLED ON (B)(6) 2019 AT 9:07AM WITH A RECOVERY ON (B)(6) 2019 AT 10:38AM, STALLED ON (B)(6) 2019 AT 12:52PM WITH A RECOVERY ON (B)(6) 2019 AT 9:19PM, STALLED ON (B)(6) 2019 AT 11:53PM WITH A RECOVERY ON (B)(6) 2019 AT 9:58PM, STALLED ON (B)(6) 2019 AT 2:34AM WITH A RECOVERY ON (B)(6) 2019 AT 3:05PM, STALLED ON (B)(6) 2019 AT 8:37PM WITH A RECOVERY ON (B)(6) 2019 AT 4:18AM, STALLED ON (B)(6) 2019 AT 1:02AM WITH A RECOVERY ON (B)(6) 2019 AT 5:13AM, STALLED ON (B)(6) 2019 AT 6:29AM WITH A RECOVERY ON (B)(6) 2019 AT 7:12AM, STALLED ON (B)(6) 2019 AT 9:52AM WITH A RECOVERY ON (B)(6) 2019 AT 6:19AM, AND STALLED ON (B)(6) 2019 AT 2:17AM WITH A RECOVERY ON (B)(6) 2019 AT 9:32PM. IT WAS NOTED THAT SURGICAL INTERVENTION OCCURRED AS PUMP REPLACEMENT WAS PERFORMED ON (B)(6)2019. THE PUMP WOULD BE RETURNED FOR ANALYSIS. IT WAS NOTED THAT THE ISSUE WAS RESOLVED AT TIME OF REPORT. THE PATIENT'S STATUS AT TIME OF REPORT WAS ALIVE- NO INJURY. THE PATIENT'S WEIGHT WAS 60KG. THE PATIENT'S MEDICAL HISTORY WAS ASKED AND WILL NOT BE MADE AVAILABLE. THE EVENT DATE WAS (B)(6) 2019. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105519 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169100824

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention