BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4137

    MDR report key: 3021808 · Received March 26, 2013

    Report

    Report Number
    1028232-2013-00742
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    January 27, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS OF THE LEAD DEMONSTRATED A DAMAGED INSULATION AND A FRACTURED OUTER COIL AT A DISTANCE OF SOME 27.5 CM DISTAL TO THE IS-1 CONNECTOR PIN. IN THAT SECTION, THE LEAD BODY WAS FOUND SQUEEZED AND DEFORMED. BASED ON THE CHARACTERISTICS AS WELL AS THE LOCATION OF THESE DAMAGES, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO EXCESSIVE MECHANICAL FORCES AS THE RESULT OF CLAVICULAR FIRST RIB ENTRAPMENT. FURTHER INSPECTION REVEALED INSULATION DAMAGES IN THE DISTAL PART OF THE LEAD, WHICH WAS MOST LIKELY CAUSED BY AN INTERACTION BETWEEN THE LEAD AND THE TRICUSPID VALVE. THESE DAMAGES CAN BE CONSIDERED AS THE ROOT CAUSE OF THE OBSERVED ISSUES AS MENTIONED IN THE COMPLAINT DESCRIPTION. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR LEAD PRESENTED IN THE ER FOR AN UNSPECIFIED REASON. UPON REVIEW, THE RV LEAD DISPLAYED NOISE AS WELL AS PACING IMPEDANCE MEASUREMENTS OF 160 OHMS. NO PACING INHIBITION WAS OBSERVED, AS THE PATIENTS OWN INTRINSIC RHYTHM WAS APPROPRIATE. A REVISION PROCEDURE WAS PERFORMED. THE LEAD WAS EXPLANTED. UPON VISUAL INSPECTION, THE PHYSICIAN OBSERVED EROSION ON THE LEAD INSULATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124782 DEXTRUS 4137 PACER LEAD NVN BIOTRONIK SE & CO. KG 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization