BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4137

    MDR report key: 3231501 · Received July 17, 2013

    Report

    Report Number
    1028232-2013-01917
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    May 16, 2013
    Report Date
    July 2, 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 INSPECTION. THE ANALYSIS OF THE LEAD DEMONSTRATED A DAMAGED INSULATION AT APPROX. 55 CM DISTAL TO THE IS-1 CONNECTOR PIN. THIS INSULATION DAMAGE CAN BE CONSIDERED TO BE THE ROOT CAUSE OF OBSERVED NOISE 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 MECHANICAL INTERACTION BETWEEN THE LEAD BODY AND THE TRICUSPID VALVE. DIAGNOSTIC IMAGES CLARIFYING THIS ASSUMPTION WERE NOT AVAILABLE FOR ANALYSIS. FURTHER DAMAGES OCCURED 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 NOISE WAS NOTED ON THE RIGHT VENTRICULAR LEAD. THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF NOISE WAS UNKNOWN. AN EXPLANT DATE WAS PROVIDED SO IT IS UNCLEAR IF THE DEVICE IS STILL ACTIVELY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332215 DEXTRUS 4137 PACER LEAD NVN BIOTRONIK SE & CO. KG 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization