BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1870753 · Received October 12, 2010

    Report

    Report Number
    3007566237-2010-07872
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 15, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED AN UNDERDOSE WITH MODERATE SYMPTOMS OF WITHDRAWAL WHICH WERE MANAGED ORALLY. AN ALARM WAS HEARD AND CONFIRMED BY TELEMETRY. TELEMETRY CONFIRMED A CRITICAL ALARM WAS OCCURRING DUE TO A MOTOR STALL, WHICH WAS CONSTANT. PER THE REPORTER, PUMP LOGS REVEALED A LOW BATTERY RESET OCCURRED AT 8:08 AM ON (B)(6) 2010. IT WAS NOTED THERE WAS A PREMATURE ESTIMATED REPLACEMENT INDICATOR (ERI) ALARM; THE BATTERY WAS SCHEDULED TO BE REPLACED BY (B)(6) 2010. THE PUMP WAS EXPLANTED AND REPLACED ON (B)(6) 2010. THE BATTERY WAS DEPLETED. A ROTOR AND DYE STUDY WERE NOT PERFORMED. THE PUMP DELIVERED LIORESAL INTRATHECAL (BACLOFEN) OF CONCENTRATION 2,000 MCG/ML AT A DOSE OF 1,048.7 MCG/DAY. THERE WAS NO PT INJURY. THE PT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8731, LOT # N002780716