BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202740 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-01247
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    April 10, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8711, LOT# N076782012, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. PRODUCT ID: 8840, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER. PHYSICIAN PRODUCT ID: 8840, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER. PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2012, AN ALARM OCCURRED DUE TO LOW RESERVOIR VOLUME REACHED. THE PUMP WAS NOT UPDATED AT A REFILL ON (B)(6) 2012, SO THE LOW RESERVOIR ALARM OCCURRED DESPITE THE PUMP HAVING APPROXIMATELY 15.5 MILLILITERS (ML) IN THE PUMP. THE PATIENT EXPERIENCED SOME SWEATING AFTER THE PUMP ALARM. IT WAS LATER REPORTED ON (B)(6) 2012, THE PATIENT HAD NO SYMPTOMS AND THE PUMP WAS UPDATED WITH THE CORRECT VOLUME AND THE ALARM STOPPED. THE PUMP WAS USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302955 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1