BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1802356 · Received August 11, 2010

    Report

    Report Number
    3007566237-2010-06034
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 15, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    A PT HAD EXPERIENCED INCREASED PAIN. A "ROTOR STALL" IN REGARDS TO THE PT'S PUMP OCCURRED DURING THE WEEK OF (B)(6)2010. THE PUMP WAS REPLACED AND THE PT WAS RELEASED FROM THE HOSPITAL THE FOLLOWING DAY. FENTANYL WAS BEING ADMINISTERED BY THE PUMP. FENTANYL WAS INCREASED IN RESPONSE TO THE INCREASED PAIN, BEFORE IT WAS REALIZED THAT THE PUMP WAS MALFUNCTIONING. CONCENTRATION AND DAILY DOSE OF THE FENTANYL WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 61 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8731, LOT # N005189123| IMPLANTED: