BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5995297 · Received October 3, 2016

    Report

    Report Number
    3004209178-2016-20299
    Event Type
    Injury
    Date Received
    October 3, 2016
    Date of Event
    September 24, 2016
    Report Date
    October 26, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM HEALTH CARE PROVIDER (HCP) INDICATED THE PATIENT FIRST EXPERIENCED THE ALARM ON (B)(6) 2016 AND HAD INCREASED SPASTICITY AND ITCHING. THE PUMP ALARMED AND WAS IN SAFE MODE DUE TO BATTERY ELECTIVE REPLACEMENT INDICATOR (ERI) AND THE BATTERY WAS DUE FOR PUMP EXCHANGE. THE PATIENT WAS SCHEDULED FOR PUMP EXCHANGE FOR (B)(6) 2016 AND THE PUMP WAS IN SAFE STATE. THE PATIENT WAS ON ORAL BACLOFEN 30 MG-40 MG PO TID STARTING (B)(6) 2016 AND LORAZEPAM, TRAMADOL 50 PO, INTRATHECAL LIORESAL 2000 MCG/ML AT 12.2 MCG/DAY. UPON REFILL PROCEDURE ON (B)(6) 2016, IT WAS NOTED THE PUMP HAD AUTOMATICALLY GONE INTO SAFE STATE. THE TELEMETRY LOGS CONFIRMED THE PUMP WAS IN SAFE STATE AND A RESET OCCURRED. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIPLE SCLEROSIS AND SPASTICITY. ADDITIONAL INFORMATION FROM THE MANUFACTURER'S REPRESENTATIVE (REP) ON (B)(6) 2016 STATED THE PUMP WAS REPLACED THAT DA Y AND THE PATIENT'S STARTING DOSE WAS 25 MCG.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURE'S REPRESENTATIVE REGARDING A PATIENT RECEIVING UNKNOWN MEDICATION VIA AN IMPLANTED PUMP. THE INDICATION FOR PUMP USE WAS INTRACTABLE SPASTICITY. IT WAS REPORTED THE PATIENT'S PUMP WAS ALARMING. THE HEALTHCARE PROVIDER WAS GOING TO COVER THE PATIENT WITH ORAL MEDICATION AND MONITOR FOR SIGNS AND SYMPTOMS OF WITHDRAWAL. ON (B)(6) 2016 E1A (HCP,REP): ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURE'S REPRESENTATIVE STATING THE PATIENT'S PUMP WAS NOT DEAD BUT WAS CLOSE TO ERI, AND THE PATIENT KEPT RESCHEDULING THE REPLACEMENT SURGERY. IT WAS REPORTED THE PATIENT IS SCHEDULED TO GET THE NEW PUMP IMPLANTED ON TUESDAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645614 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention