BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3914125 · Received July 3, 2014

    Report

    Report Number
    3004209178-2014-12541
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-3043-2011, Z-2276-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    ANALYSIS OF THE PUMP FOUND NO ANOMALY. THE PUMP WAS IMPLANTED FOR ONLY 28 MONTHS, BUT THE ESTIMATED ELECTIVE REPLACEMENT INDICATOR (ERI) IN ONE MONTH WAS DUE TO MOTOR REVOLUTIONS. (B)(4).

    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, THE PUMP WAS EXPLANTED ON 2014 (B)(6) DUE TO PREMATURE BATTERY DEPLETION. THE PATIENT STATUS WAS NOTED AS ALIVE WITH NO INJURY. NO PATIENT SYMPTOMS WERE REPORTED. THE PUMP WAS USED TO DELIVER BACLOFEN, DILAUDID, AND BUPIVACAINE. ADDITIONAL INFORMATION NOTED THE PUMP DELIVERED COMPOUNDED BACLOFEN. IT WAS REPORTED, THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. IT WAS STATED, THE HIGH FLOW OF THE PATIENT¿S PUMP WOULD CAUSE THE BATTERY TO DEPLETE FASTER. IT WAS STATED, THE NEW PUMP CURRENTLY HAD AN ELECTIVE REPLACEMENT INDICATOR (ERI) AT 54 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390824 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Required Intervention