BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3250371 · Received July 26, 2013

    Report

    Report Number
    3004209178-2013-12362
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    June 15, 2013
    Report Date
    July 2, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1579-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED PUMP/MOTOR/FEEDTHRU ANOMALY/SHORTING ACROSS INSULATOR. DURING ANALYSIS CORROSION AND BRIDGING ACROSS THE INSULATION OF THE M2 FEEDTHRU WAS FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS ALARMING CRITICALLY AND CONFIRMED BY TELEMETRY DUE TO ¿RESET OCCURRED - LOW BATTERY¿. IT WAS REPORTED THAT THE PUMP WAS INTERROGATED AS OF THE DATE OF THIS REPORT WHEN PATIENT VISITED THE CLINIC. THE RESET HAD OCCURRED ON (B)(6) AND THE DOSE WAS BLANK ON THE PROGRAMMER. PATIENT HAD NOT SEEN THE PHYSICIAN SINCE THE PUMP HAD STARTED ALARMING ON (B)(6). IT AS REVIEWED THAT THE PUMP WOULD BE INFUSING AT MINIMUM RATE MODE .006ML/DAY. PATIENT WAS SUPPLEMENTED WITH ORAL BACLOFEN. THE ERI (ELECTIVE REPLACEMENT INDICATOR) WAS INDICATED TO BE 18 MONTHS ON (B)(6) 2013. DRUG DELIVERED VIA THE DEVICE WAS GABLOFEN. IT WAS LATER REPORTED THAT PATIENT HAD EXPERIENCED INCREASED SPASTICITY. PATIENT WAS ON ORAL BACLOFEN AND RESPONDING BETTER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS STATED THAT THE PUMP WAS IN SAFE STATE FOLLOWING THE LOW BATTERY RESET. THE PUMP WAS BEING REPLACED AS OF THE DATE OF THIS REPORT. UPON READING THE PUMP LOGS, THE REPORTER STATED THAT THERE WAS A MOTOR STALL ON (B)(6) AND A RESET-LOW BATTERY MESSAGE ON (B)(6). THE DOSE SECTION WAS BLANK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350144 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention