BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 210134 · Received February 11, 1999

    Report

    Report Number
    6000030-1999-00045
    Event Type
    Malfunction
    Date Received
    February 11, 1999
    Date of Event
    December 14, 1998
    Report Date
    January 4, 1999
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED WITH THE SYNCHROMED PUMP FOR PAIN THERAPY ON 12/08/1997 TO DELIVER MORPHINE SULFATE AND CLONIDINE. PT REPORTED A DECREASE IN PAIN RELIEF AS WELL AS NAUSEA, CHILLS, AND DIARRHEA OVER A 24 HOUR PERIOD. THE PT'S PUMP WAS REFILLED AND THEN ON X-RAY EXAM OF THE ROTOR IT WAS FOUND TO BE NOT PUMPING. THE PUMP WAS EXPLANTED AND THE PT WAS REIMPLANTED WITH ANOTHER SYNCHROMED PUMP ON 12/14/1998. HEALTH CARE PROFESSIONAL REPORTS THAT THE PT'S CONDITION IS IMPROVED AND AT HIS BASELINE. PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED Implant IMPLANTABLE INFUSION PUMP LKK MEDTRONIC, INC. 8617L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization EXPLANTED 12/14/1998.| INDURA INTRASPINAL CATHETER IMPLANTED 12/08/1997,