BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2878063 · Received December 18, 2012

    Report

    Report Number
    3007566237-2012-03048
    Event Type
    Injury
    Date Received
    December 18, 2012
    Report Date
    November 19, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), PRODUCT TYPE CATHETER: PRODUCT ID 8590-1, LOT# N143360, IMPLANTED: 2008-(B)(6), PRODUCT TYPE ACCESSORY. (B)(4): ANALYSIS OF THE PUMP REVEALED NO ANOMALY FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED PAIN WITH A LACK OF ADEQUATE PAIN RELIEF. IT WAS NOTED LESS THAN 50% THERAPY RELIEF. NO ROLLER OR DYE STUDY WAS PERFORMED. A REVISION WAS DONE AND THE PUMP WAS REPLACED DUE TO BATTERY DEPLETION. IT WAS UNKNOWN WHY IT WAS EXPLANTED PREMATURELY. THE PATIENT STATUS WAS ALIVE - NO INJURY/NO ADVERSE EVENT. THE PUMP WAS DELIVERING MORPHINE AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention