BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 2100319 · Received May 16, 2011

    Report

    Report Number
    3007566237-2011-03565
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Report Date
    April 19, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    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

    ON (B)(6) 2011 IT WAS INITIALLY REPORTED THAT DURING IMPLANT, A PHYSICIAN HAD DIFFICULTY WITH CATHETER INSERTION/ADVANCEMENT. THE DISTAL/INTRATHECAL END OF THE CATHETER WAS BENDING OR CURVING, AFTER THE CATHETER WAS ADVANCED A FEW CENTIMETERS FROM THE END OF THE NEEDLE. THE CATHETER HAD BEEN REMOVED, AND ANOTHER WAS USED IN ITS PLACE. IT WAS NOTED THAT THE PHYSICIAN WAS FOLLOWING PROPER PARAMEDICAL TECHNIQUE AND PROPER PROCEDURE. IT WAS FURTHER INDICATED THAT THE ISSUE HAD OCCURRED WITH THE PHYSICIAN'S LAST 5 TO 6 CASES. THE CATHETERS WERE PLANNED TO BE SENT BACK TO THE MANUFACTURER FOR ANALYSIS. ON (B)(6) 2011: ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE REPORTER WAS NOT PRESENT AT ALL OF THE PHYSICIAN'S CASES, IN WHICH THE SAME ISSUE HAD OCCURRED. THE PATIENT OUTCOMES WERE NOTED AS BEING "ALL FINE SO FAR", IN ADDITION TO NO PATIENT INJURY. THE MEDICATION DELIVERED VIA THE PUMP WAS LIORESAL. ADDITIONAL INFORMATION 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 SYNCHROMED LKK MEDTRONIC NEUROMODULATION UNKNOWN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CATHETER: MODEL 8731SC, LOT# UNKNOWN| IMPLANTED:| EXPLANTED: