BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3902560 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-12273
    Event Type
    Injury
    Date Received
    June 30, 2014
    Report Date
    June 9, 2014
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MANUFACTURER'S REPRESENTATIVE GOT A CALL FROM THE HEALTHCARE PROFESSIONAL (HCP) THAT THERE WAS A PATIENT WITH A SUSPECTED OVERDOSE AND OVERINFUSION OF THE PUMP. IT WAS NOTED THAT ON (B)(6) 2014, THE PATIENT'S PUMP WAS REFILLED, AND THEY WERE EXPECTING 3 MLS AND THE ACTUAL WAS 0 MLS. BEFORE THAT, A REFILL WAS ON (B)(6) 2014 AND THE EXPECTED WAS 5.2 AND THE ACTUAL WAS 7 MLS. IT WAS NOTED THAT THERE WAS NO DOSE CHANGE ON (B)(6) 2014 BUT 12 HOURS LATER THE PATIENT SHOWED OVERDOSE SYMPTOMS. THE DOSE WAS DECREASED BY 30 % AND THE PATIENT REPORTEDLY DID OKAY AND RECOVERED. IT WAS NOTED THAT ON (B)(6) 2014, THE PATIENT WAS READMITTED WITH OVERDOSE SYMPTOMS AND THEY DECREASED THE DOSAGE ANOTHER 30 %. IT WAS NOTED THAT 34.8 MLS WAS EXPECTED IN THE RESERVOIR ON THE DAY OF REPORT, BUT IT HAD NOT BEEN ASPIRATED AT THAT TIME. THE PUMP WAS USED TO DELIVER INTRATHECAL BACLOFEN. IT WAS LATER REPORTED THAT DURING THE PATIENT VISIT ON (B)(6) 2014, THE PATIENT WAS HAVING AN EPISODE OF ATHETOSIS. THE PROGRAMMER VOLUME WAS REPORTED TO BE 3.8 MLS WITH THE ACTUAL BEING 0 ML. IT WAS NOTED THAT THERE WAS MINIMAL VOLUME IN THE TUBING. THE OVERINFUSION WAS NOT ABLE TO BE CONFIRMED WITH A REPORTED UNKNOWN CAUSE. THE PUMP WAS REPORTEDLY REFILLED ON (B)(6) 2014 AND REPROGRAMMED ON (B)(6) 2014 DUE TO AN EPISODE OF WHAT APPEARED TO BE BACLOFEN OVERDOSE WITH REPORTED SYMPTOMS OF SOMNOLENCE, DIFFICULTY TO AROUSE, WITH BRADYCARDIA. THE PATIENT WAS REPORTEDLY BROUGHT BACK TO THE CLINIC ON (B)(6) 2014 AND 34.5 ML OF BACLOFEN WAS ASPIRATED FROM THE PUMP WAS AN EXPECTED OF 34.8 MLS. IT WAS NOTED THAT THE PATIENT WAS DOING WELL AND WAS TO RETURN TO THE CLINIC ON (B)(6) 2014 TO CHECK THE VOLUME OF THE BACLOFEN IN THE PUMP. THE PATIENT REPORTEDLY RECOVERED WITHOUT PERMANENT IMPAIRMENT. IT WAS NOTED THAT IT WAS "THOUGHT TO BE SEIZURE RELATED". IT WAS LATER REPORTED THAT THE PUMP WAS OUT OF MEDICATION AND THE PATIENT EXPERIENCED WITHDRAWAL. THE PATIENT WAS GOING TO BE BROUGHT IN ON (B)(6) 2014 FOR FINAL CONFIRMATION OF OVERINFUSION. THE PATIENT WAS REPORTEDLY STABLE PER WHAT THE MANUFACTURER'S REPRESENTATIVE KNEW. THE PUMP SESSION DATA SENT. IT WAS SHOWN THAT ON (B)(6) 2014 THE DAILY DOSE WAS DECREASED 21%. IT WAS NOTED THAT THE LOW RESERVOIR ALARM DATE WAS EXPECTED ON (B)(6) 2014. IT WAS ADDED THAT ON (B)(6) 2014, THE EXPECTED RESERVOIR VOLUME WAS 3.6 ML AND THE ACTUAL WAS 5 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379973 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00016 YR Required Intervention