BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2102329 · Received May 20, 2011

    Report

    Report Number
    3007566237-2011-03703
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 22, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS GOING THROUGH WITHDRAWAL. THE PATIENT HAD FLU LIKE SYMPTOMS AND INCREASED BASELINE PAIN. THE PATIENT WENT TO THE DOCTOR'S OFFICE AND IT WAS DISCOVERED THAT THERE WAS A 50% REDUCTION IN THE DRUG. IT WAS SUSPECTED THAT THE DRUG WAS NOT GOING DIRECTLY TO THE SITE. A DYE STUDY WAS PERFORMED, BUT THE RESULTS WERE NOT BACK. THERE WERE NO ALARMS COMING FROM THE DEVICE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCE INCREASED BASELINE PAIN. ADJUSTMENTS HAD NOT AFFECTED THE PAIN. THE SYMPTOMS OCCURRED DURING A NORMAL REFILL CYCLE, AND OCCURRED OVER THE ENTIRE SYSTEM. A ROLLER STUDY WAS PERFORMED, NO PROBLEMS WERE FOUND. A (B)(6) STUDY WAS SCHEDULED. THE PHYSICIAN THOUGHT THERE COULD BE AN ISSUE WITH A KINKED OR DISCONNECTED CATHETER. THE LOGS DID SHOW A MOTOR STALL WHICH OCCURRED WHEN THE PATIENT HAD AN MRI, BUT THE STALL CLEARED AN HOUR LATER AS EXPECTED. IT WAS NOTED THAT THE PATIENT WAS AT HOME IN FAIR CONDITION. THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS DILAUDID. 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
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR IMPLANTED:| CATHETER: MODEL 8703W, LOT# L53269| EXPLANTED: