BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1840085 · Received September 15, 2010

    Report

    Report Number
    3007566237-2010-07000
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 16, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING WITHDRAWAL. THE EVENT OCCURRED DURING A NORMAL REFILL CYCLE. THE PATIENT WAS ON VACATION (B)(6) 2010, WHEN HE "STARTED FEELING SICK" AND THE PUMP STARTED ALARMING. THE PATIENT WAS TAKEN TO THE ER WHERE THE PUMP WAS INTERROGATED AND REVEALED A MOTOR STALL. THE PATIENT WAS AT HOME AT THE TIME OF THE REPORT, STILL EXPERIENCING WITHDRAWAL SYMPTOMS. THE PATIENT WAS PLANNING TO SEE HIS PHYSICIAN ON (B)(6)2010 FOR MANAGEMENT OF WITHDRAWAL AND TO DISCUSS REPLACEMENT. THE MEDICATIONS IN THE PUMP INCLUDED FENTANYL, CLONIDINE, BUPIVACAINE, HYDROMORPHONE AND BACLOFEN, DOSAGE AND CONCENTRATION WERE UNK. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT 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 41 YR CATHETER: MODEL #8709, LOT #J12016R33| EXPLANTED:| IMPLANTED: