BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 3000385 · Received March 12, 2013

    Report

    Report Number
    1028232-2013-00573
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    January 24, 2013
    Report Date
    February 26, 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 PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL AND AN ELECTRICAL ANALYSIS. THE ANALYSIS REVEALED A DAMAGED INSULATION AT A DISTANCE OF SOME 29.5 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 THE DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO EXCESSIVE MECHANICAL FORCES AS THE RESULT OF CLAVICULAR FIRST RIB ENTRAPMENT. THE DEFORMATION OF THE OUTER COIL IN THE PROXIMAL PART OF THE LEAD OCCURRED MOST LIKELY DURING THE EXPLANTATION PROCEDURE. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD WAS EXPLANTED DUE TO REPAIR/UPGRADE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THE LEAD EXHIBITED LOSS OF CAPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103037 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization