BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICROTARGETING DRIVE SYSTEM

    MDR report key: 381035 · Received March 8, 2002

    Report

    Report Number
    1226598-2002-00001
    Event Type
    Death
    Date Received
    March 8, 2002
    Report Date
    March 6, 2002
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED THAT A PT HAD DIED FROM INTRACRANIAL BLEEDING. A MICROTARGETING DRIVE SYSTEM WAS IN USE AT THE TIME FOR THE PURPOSE OF IMPLANTING A DEEP BRAIN STIMULATOR. THE DISTRIBUTOR REPORTED THAT AS A SPACER TUBE WAS BEING WITHDRAWN, A GUIDE TUBE FOLLOWED THE SPACER TUBE UP. INSTEAD OF RE-INSERTING A STYLET INTO THE GUIDE TUBE (AS PER PRINTED INSTRUCTIONS) BEFORE PUSHING THE GUIDE TUBE BACK DOWN, THE GUIDE TUBE WAS PUSHED BACK WITHOUT THE STYLET. THEREFORE, RE-INSERTION OF THE GUIDE TUBE WITHOUT A STYLET WAS BELIEVED TO HAVE CAUSED THE BLEEDING. HOWEVER, ALMOST NO INFORMATION ABOUT THE CASE HAS BEEN MADE AVAILABLE TO THE CO AT THIS TIME, SO DRAWING ANY RATIONAL CONCLUSIONS REGARDING THIS EVENT IS PRACTICALLY IMPOSSIBLE.

    Description of Event or Problem · 1

    CO HAS REC'D AN EMAIL FROM RPTR IN ANSWER TO CO'S REQUIRES FOR FURTHER INFO CONCERNING THE ADVERSE EVENT DESCRIBED IN CO'S INITIAL REPORT. RPTR REPORTS THAT THE DOCTOR IN THE CASE STATED, "THEY CANNOT BLAME THE PRODUCTS AT ALL, BLEEDING DO[ES] OCCUR IN THIS KIND OF PROCEDURE". RPTR GOES ON TO SAY THAT MEDTRONIC FUNCTIONAL DIAGNOSTICS DOES NOT PLAN TO SUBMIT A REPORT TO EITHER THEIR NOTIFIED BODY OR COMPETENT AUTHORITY. THEREFORE, FHC, INC. DOES NOT ANTICIPATE RECEIVING ANY FURTHER INFO ABOUT THIS CASE. AS A RESULT, CO IS ISSUING THIS FOLLOW-UP IN ORDER UPDATE CO'S PREVIOUS NI RESPONSES TO UNK, WHERE APPROPRIATE. HOWEVER, AS STATED IN THE PREVIOUS REPORT CO CONTINUES TO INTEND TO NOTIFY CO'S CURRENT FHC CUSTOMERS AND AMEND CO'S INSTRUCTIONS WITH A CAUTION REGARDING REINSERTION FOLLOWING INADVERTENT DISPLACEMENT OF CO'S GUIDE TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTARGETING DRIVE SYSTEM STEREOTACTIC MICROPOSITIONER HAW FHC, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death