BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 2822078 · Received October 9, 2012

    Report

    Report Number
    1028232-2012-02446
    Event Type
    Malfunction
    Date Received
    October 9, 2012
    Date of Event
    August 23, 2012
    Report Date
    September 20, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    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. THE ANALYSIS OF THE LEAD DEMONSTRATED MULTIPLE SIGNS OF ABRASION. FURTHER ANALYSIS INDICATED A DAMAGED ISOLATION AT THE DISTAL PART OF THE LEAD. DURING THE ELECTRICAL INSPECTION A SHORT CIRCUIT BETWEEN THE INNER AND OUTER COIL WAS DETECTED. 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. FURTHERMORE DEFORMATIONS OF THE INNER COIL CLOSE TO THE IS-1 CONNECTOR PIN AS WELL AS CUTTINGS IN THE ISOLATION WERE DETECTED. THOSE DAMAGES 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 (RV) LEAD EXHIBITED NOISE, THE PATIENT EXPERIENCED A JUMPING SENSATION WHEN THE RV LEAD PACED. THE LEAD WAS SUCCESSFULLY EXPLANTED AND A NEW LEAD IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization