BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2031575 · Received March 25, 2011

    Report

    Report Number
    3007566237-2011-02156
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 27, 2011
    Report Date
    February 28, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP HAS BEEN RETURNED TO THE MFR FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT BEGAN HEARING AN ALARM ON (B)(6) 2011. THE PT EXPERIENCED INCREASED SPASMS AND SWEATING. THE PUMP WAS INTERROGATED ON (B)(6) 2011 AND A MOTOR STALL OCCURRED THE DAY BEFORE. THE PT WAS STARTED ON ORAL BACLOFEN AND ATIVAN IV, TO CONTROL BACLOFEN WITHDRAWAL SYMPTOMS. THE ELECTIVE REPLACEMENT INDICATOR ON THE PT'S PUMP READ 21 MONTHS. THE PT'S PUMP WAS REPLACED AND THERE WAS NO INJURY REPORTED. THE MEDICATION BEING DELIVERED VIA THE DEVICE WAS LIORESAL 2000 MCG/ML. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# L69916