BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1864330 · Received October 7, 2010

    Report

    Report Number
    3007566237-2010-07725
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    July 28, 2010
    Report Date
    August 1, 2010
    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

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS UNABLE TO SET A BOLUS WITH THE PROGRAMMER, WHICH DISPLAYED CODE 8473 (CRITICAL GENERIC). LOGS INDICATED A MOTOR STALL. ANOTHER PROGRAMMER WAS USED UNSUCCESSFULLY, WITH CODES 8532 (CRITICAL STOPPED PUMP) AND 8476 (MOTOR OPEN COIL OR STALL) DISPLAYED. THE PT HAD BEEN FEELING PAIN SINCE (B)(6). THE PUMP WAS REPLACED ON (B)(6) 2010. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE MORPHINE, CLONIDINE, AND BUPIVACAIN. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL PTM, LOT# UNK