BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1222429 · Received November 5, 2008

    Report

    Report Number
    2182207-2008-07231
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 8, 2008
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS EXPLANTED AND REPLACED DUE TO MOTOR STALL. "PUMP WOULD STALL THEN START". THE PUMP CONTAINED FENTANYL 2000 MCG/ML AT 12.1 MCG/DAY; DILAUDID 2.5 MG/ML AT 0.0151 MG/DAY; BACLOFEN 90 MCG/ML AT 0.543 MCG/DAY AND CLONIDINE 40 MCG/ML AT 0.242 MCG/DAY. NO PATIENT SYMPTOMS OR OUTCOME WERE REPORTED.

    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 50 YR Required Intervention CATHETER MDOEL 8703W LOT# J0039914R| EXPLANTED:| PROGRAMMER MODEL 8840 LOT# UNKNOWN| IMPLANTED:| CATHETER MODEL 8596 LOT# N056400013| IMPLANTED:| EXPLANTED: