BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 1181896 · Received September 25, 2008

    Report

    Report Number
    1028232-2008-01136
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    June 30, 2008
    Report Date
    August 25, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.,
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MECHANICAL PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM. THE VISUAL INSPECTION DEMONSTRATED A BEND IN THE LEAD'S DISTAL PART. BENDING THE DISTAL PART REQUIRES THE PRESENCE OF MECHANICAL STRESS. THERE WAS NO EVIDENCE OF A MATERIAL OR MANUFACTURING PROBLEM. MECHANICAL STRESS WHILE IMPLANTING/EXPLANTING THE LEAD SHOULD BE TAKEN INTO CONSIDERATION. THE ANALYSIS DEMONSTRATED THAT A STYLET COULD NOT BE PROPERLY INTRODUCED AND ADVANCED WITHIN THE LEAD'S LUMEN. THUS THE FUNCTIONAL TEST OF THE HELIX FIXATION MECHANISM WAS NOT PROPERLY FEASIBLE. THIS WAS DUE TO SEVERE DEFORMATIONS OF THE INNER WIRING NEAR THE CONNECTOR PIN. DAMAGE SYMPTOMS SUCH AS THOSE REQUIRE THE PRESENCE OF INTENSE MECHANICAL STRESS. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM. THE CHARACTERISTICS OF THE DAMAGES INDICATE THAT THE DAMAGE WAS DUE TO OVERROTATION OF THE INNER WIRING. FURTHERMORE, THE VISUAL INSPECTION DEMONSTRATED DEFORMATIONS OF THE COIL AND CUTTINGS WITHIN THE OUTER INSULATION. THESE DAMAGES ARE MOST LIKELY DUE TO MECHANICAL STRESS DURING THE IMPLANTATION PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD HAD INCREASING THRESHOLD MEASUREMENTS TO 3.5 VOLTS. THE PHYSICIAN ELECTED TO REPLACE THE LEAD RATHER THAN REPOSITION IT. AS A RESULT, A NEW RV LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD DTB BIOTRONIK GMBH AND CO., 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization