BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1926402 · Received November 11, 2010

    Report

    Report Number
    3007566237-2010-09364
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 27, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT'S PUMP HAD BEEN ALARMING SINCE (B)(6) 2010. TELEMETRY HAD NOT BEEN PERFORMED. THE PATIENT MISSED A REFILL AND WAS EXPERIENCING ACUTE PAIN AND SWEATING. SHE STATED THAT THE PUMP "DIED" ON (B)(6) 2010. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. 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 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8703, LOT# UNKNOWN