BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCRHOMED II

    MDR report key: 2181474 · Received July 5, 2011

    Report

    Report Number
    3007566237-2011-05089
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 13, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S SYMPTOMS HAD RETURNED, WITH NO IMPROVEMENT IN PAIN SINCE 2-3 WEEKS POST DEVICE SYSTEM IMPLANT. THEY ALSO SAW "SOME SWELLING OVER THE PUMP". IT WAS LATER REPORTED THAT THE ACTUAL RESIDUAL VOLUME WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME. THREE WEEKS AFTER PUMP REPLACEMENT, THEY HAD EXPECTED 8.1ML IN THE RESERVOIR AND ASPIRATED 18.1ML. THE PT HAD UNDERDOSE SYMPTOMS OF INCREASED PAIN. THE PHYSICIAN OPTED TO REFILL THE PUMP WITH 20 ML OF CHANGED MEDICATION AND HAVE THE 18ML OF MEDICATION ANALYZED FOR MEDICATION CONTENTS/CONCENTRATIONS. CATHETER ISSUE WAS EXPECTED AND DIAGNOSTIC TESTING WAS TO BE PERFORMED. THE PHYSICIAN DECIDED TO HAVE THE PT RETURN IN 2.5 TO 3 WEEKS AND REMOVE MEDICATION AND SEE IF THE SAME PROBLEMS RECURRED. PT HOWEVER, HAD REPORTED NO CHANGE IN PAIN RELIEF FROM PRIOR. THE DRUGS INFUSED VIA THE PUMP WERE MORPHINE AND BUPIVACAINE (MARCAINE). ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR IMPLANTED:| EXPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 863720,| EXPLANTED:| EXPLANTED:| LOT# NGP007796N| IMPLANTED:| CATHETER: MODEL 8709, LOT# J12063R18| IMPLANTED:| CATHETER: MODEL 8578, LOT# UNK