BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1559472 · Received December 10, 2009

    Report

    Report Number
    3007566237-2009-09251
    Event Type
    Injury
    Date Received
    December 10, 2009
    Date of Event
    November 14, 2009
    Report Date
    November 16, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THE HEALTH CARE PROFESSIONAL REPORTED A PUMP MOTOR STALL IN 2009 WITH NO RECOVERY NOTED. THE PUMP WAS NOTED TO HAVE STALLED MULTIPLE TIMES. THE PT HAD EXPERIENCED UNDERDOSE AND WITHDRAWAL SYMPTOMS WHICH INCLUDED INCREASED BASELINE PAIN. THE PUMP WAS REPLACED AND THE CATHETER WAS NOT EXPLANTED. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS DILAUDID. 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 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention EXPLANTED:| PROGRAMMER: MODEL 8840, LOT# UNK| IMPLANTED:| CATHETER: MODEL 8709, LOT# L57101