BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 3874228 · Received June 16, 2014

    Report

    Report Number
    1028232-2014-01972
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 31, 2013
    Report Date
    June 5, 2014
    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

    UPON RECEIPT, THE LEAD WAS FOUND DISSECTED AT 52 CM PROXIMAL TO THE TIP. ONLY THE DISTAL SEGMENT WAS RECEIVED FOR ANALYSIS. THE ANALYSIS OF THE RECEIVED LEAD SEGMENT REVEALED SEVERE ABRASION MARKS IN THE AREA OF THE TRICUSPID VALVE. THE INSULATION WAS FOUND RUBBED THROUGH IN THIS AREA. THIS INSULATION DAMAGE CAN BE CONSIDERED TO BE THE ROOT CAUSE OF THE NOISE AND LOW PACING IMPEDANCE VALUES MENTIONED IN THE COMPLAINT DESCRIPTION. BASED ON THE CHARACTERISTICS AS WELL AS THE LOCATION OF THE DAMAGES, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO EXCESSIVE MECHANICAL FORCES AS THE RESULT OF MECHANICAL INTERACTION BETWEEN THE LEAD BODY AND THE TRICUSPID VALVE. FURTHER ANALYSIS REVEALED INTRA-OPERATIVE DAMAGES I.E. THE LEAD BODY WAS FOUND SEVERELY DAMAGED AT VARIOUS POSITIONS AS A RESULT OF LASER EXTRACTION. FURTHERMORE, THE FIXATION HELIX WAS FOUND BENT AND STRETCHED, THE OUTER CONDUCTOR COIL WAS FOUND STRETCHED AND THE LEAD'S DISTAL PART WAS PARTLY PULLED OUT OF THE RING ELECTRODE. TRACTION FORCES APPLIED DURING THE SURGERY SHOULD BE TAKEN INTO CONSIDERATION. 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 ATRIAL LEAD HAD IMPEDANCE MEASUREMENTS OF LESS THAN 200 OHMS AND NOISE. THE RA LEAD WAS ALSO NOTED TO HAVE SENSING ISSUES. THE NOISE WAS ABLE TO BE RECREATED AND WAS BEING TRACKED BY THE PATIENT'S DEVICE. TECHNICAL SERVICES DISCUSSED THAT GIVEN SUCH OBSERVATIONS; THERE MIGHT BE LEAD INSULATION DAMAGE. THE PATIENT WAS NOT SYMPTOMATIC AND THE PHYSICIAN WAS PROVIDED WITH OPTIONS FOR REPROGRAMMING AND ADJUSTING THE SENSITIVITY TO HELP TROUBLESHOOT THE ISSUE. ADDITIONAL INFORMATION FROM THE FIELD INDICATES THAT ANOTHER LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENT OF LESS THAN 200 OHMS WAS RECORDED. THE PATIENT'S SYSTEM WAS REPROGRAMMED TO VVIR AND THE RA LEAD WAS LATER SUCCESSFULLY EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352314 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization