BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4135

    MDR report key: 3021822 · Received March 26, 2013

    Report

    Report Number
    1028232-2013-00830
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    January 28, 2013
    Report Date
    March 15, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2013 - THE EXPLANT DATE HAS BEEN ADDED, WE WERE NOTIFIED THAT THIS DEVICE WAS RETURNED. OUTCOME WAS CHANGED TO HOSPITALIZATION. THE LEAD WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED INCLUDING A VISUAL, A MECHANICAL AND AN ELECTRICAL ANALYSIS. THE INSPECTION OF THE LEAD DEMONSTRATED A DAMAGED INSULATION AND A FRACTURED OUTER COIL AT A DISTANCE OF SOME 22.5 CM DISTAL TO THE IS-1 CONNECTOR PIN. IN THAT SECTION, THE LEAD BODY WAS FOUND SQUEEZED AND DEFORMED. THE DAMAGES CAN BE CONSIDERED TO BE THE ROOT CAUSE OF THE ISSUES MENTIONED IN THE COMPLAINT DESCRIPTION. 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 ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE IN-CLINIC FOLLOW UP, THE LEAD SAFETY SWITCH FEATURE WAS FOUND TO HAVE BEEN ACTIVATED FOR THIS RIGHT ATRIAL LEAD. THE LEAD EXHIBITED NOISE, HIGH THRESHOLD MEASUREMENTS AND HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,500 OHMS IN BIPOLAR CONFIGURATION. IN UNIPOLAR, PACING IMPEDANCE MEASUREMENTS WERE OBSERVED TO BE 980 OHMS AND THRESHOLD MEASUREMENTS WERE 0.9 VOLTS AT 0.4 MILLISECONDS. BOSTON SCIENTIFIC TECHNICAL SERVICES DISCUSSED A POTENTIAL LEAD FRACTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE IN-CLINIC FOLLOW UP, THE LEAD SAFETY SWITCH FEATURE WAS FOUND TO HAVE BEEN ACTIVATED FOR THIS RIGHT ATRIAL LEAD. THE LEAD EXHIBITED NOISE, HIGH THRESHOLD MEASUREMENTS AND HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,500 OHMS IN BIPOLAR CONFIGURATION. IN UNIPOLAR, PACING IMPEDANCE MEASUREMENTS WERE OBSERVED TO BE 980 OHMS AND THRESHOLD MEASUREMENTS WERE 0.9 VOLTS AT 0.4 MILLISECONDS. BOSTON SCIENTIFIC TECHNICAL SERVICES DISCUSSED A POTENTIAL LEAD FRACTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124010 DEXTRUS 4135 PACER LEAD NVN BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O