BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1061468 · Received June 13, 2008

    Report

    Report Number
    3004209178-2008-03198
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    April 24, 2008
    Report Date
    May 14, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A CATHETER REPLACEMENT, THE PATIENT HAD A LACK OF THERAPEUTIC EFFECT AND STATED THE "PUMP ISN'T WORKING." THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED; DEVICE REGISTRATION SYSTEM INDICATES MORPHINE. THE PATIENT WAS SCHEDULED FOR A DYE STUDY, BUT NO RESULTS WERE REPORTED. NO OTHER SYMPTOMS OR OUTCOME WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention CATHETER: MODEL 8709SC LOT# N143748002| PROGRAMMER: MODEL 8840 LOT# UNKNOWN| IMPLANTED:| EXPLANTED: