BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1052932 · Received May 23, 2008

    Report

    Report Number
    6000030-2008-02801
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 23, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0957-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    A VOLUME DISCREPANCY WAS REPORTED. THE EXPECTED RESERVOIR VOLUME WAS APPROXIMATELY 2 MLS; THE ACTUAL RESERVOIR VOLUME WAS 16 MLS. THE PUMP ROTOR DID NOT MOVE DURING A ROTOR STUDY (DATE OF STUDY NOT REPORTED). NO PT SYMPTOMS WERE REPORTED. PUMP REPLACEMENT WAS PLANNED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED; MFR'S DEVICE TRACKING SYSTEM INDICATES MORPHINE. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR IMPLANTED| EXPLANTED| EXPLANTED| EXPLANTED| EXTENSION MODEL# 748910| CARDIAC LEAD MODEL# 457445| EXPLANTED| IMPLANTED| CARDIAC LEAD MODEL# 407452| EMPLANTED| IMPLANTABLE CARDIAC PACEMAKER MODEL# E2DR01AA| PROGRAMMER MODEL 7435 LOT# NFT061619P| IMPLANTED| EXTENSION MODEL# 748910| IMPLANTED| EXPLANTED| IMPLANTED| LEAD MODEL# 3487A-45| IMPLANTED| IMPLANTED| PUMP PROGRAMMER MODEL PROGRAMMER LOT# UNKNOWN| CATHETER MODEL 8731 LOT# N002099111| EXPLANTED| EXPLANTED| IMPLANTABLE NEUROSTIMULATOR MODEL 7427V-NP| IMPLANTED| LEAD MODEL# 3487A-45| EXPLANTED| EXPLANTED