BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2181294 · Received July 21, 2011

    Report

    Report Number
    3007566237-2011-05641
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 30, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    UNKNOWN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3 - 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 · 0

    IT WAS LATER REPORTED THAT THE PATIENT'S PUMP WAS REPLACED ON (B)(6) 2011 THE PATIENT RECEIVED A BACLOFEN BOLUS (49 9 MCG FOR 3 MINUTES) TO PREVENT WITHDRAWAL THE PATIENT RECOVERED WITHOUT SEQUELA FOLLOWING HER PUMP REPLACEMENT PROCEDURE

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INCREASE IN TONE. TELEMETRY CONFIRMED A CRITICAL ALARM OCCURRED ON (B)(6) 2011. THE ALARM WAS IN REGARDS TO THE FOLLOWING THREE LOGGED MESSAGES: RESET OCCURRED, RESET OCCURRED - LOW BATTERY, AND SAFE STATE. A DEVICE REPLACEMENT PROCEDURE WAS PLANNED. IT WAS INDICATED THAT ERI (ELECTIVE REPLACEMENT INDICATOR) WAS SUPPOSED TO BE (B)(6) 2012. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS LIORESAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410855 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female Required Intervention CATHETER: MODEL 8709, LOT# *UK6136934.| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# *UK6136934| EXPLANTED:| IMPLANTED: