BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2874598 · Received December 15, 2012

    Report

    Report Number
    3007566237-2012-03025
    Event Type
    Injury
    Date Received
    December 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8709, LOT# J11035R21, IMPLANTED: 2002-(B)(4), EXPLANTED: UNK; CATHETER MODEL: 8578, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), EXPLANTED: UNK. (B)(4) - ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED A MOTOR GEAR TRAIN ANOMALY; CORROSION, WEAR, AND LUBRICATION WERE NOTED.

    Description of Event or Problem · 1

    A MOTOR STALL WITH NO RECOVERY WAS REPORTED; IT WAS STATED THAT THE "THERAPY WAS NOT BEING DELIVERED". PATIENT EXPERIENCED DIZZINESS. THE PUMP WAS EXPLANTED IN THE NEXT FOUR DAYS. PATIENT OUTCOME WAS NOTED AS RECOVERED WITHOUT SEQUELA. PUMP LOGS INDICATED THAT THE STALL OCCURRED ON (B)(6) 2012 AND RECOVERED ON (B)(6) 2012; DRUGS BEING INFUSED PER THE PUMP LOGS WERE MORPHINE, BUPIVACAINE AND CLONIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention