BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

    MDR report key: 3152284 · Received June 7, 2013

    Report

    Report Number
    3008973940-2013-00087
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 27, 2013
    Report Date
    April 27, 2013
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE INNER TUBING OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A TEAR, THE PROXIMAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS, THE INNER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO PULLING/STRETCHING/OVERSTRESS, AND THE INNER TUBING OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING. THE INNER INSULATION OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED STRETCHING.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PLACING THE RIGHT VENTRICULAR (RV) LEAD, MEASUREMENT VIA THE PACING SYSTEM ANALYZER (PSA) WAS PERFORMED AND THERE WAS NOTED LOW R-WAVES AND THERE WAS NO CAPTURE AT 5V. THEREFORE THE RV LEAD WAS REPOSITIONED HOWEVER, EXTENSION OF THE HELIX COULD NOT BE CONFIRMED FOLLOWING ROTATION WITH THE PINCH ON TOOL. THE RV LEAD WAS REMOVED AND HELIX EXTENSION/RETRACTION TEST WAS PERFORMED AND THE HELIX WOULD NOT EXTEND AFTER SEVERAL ROTATIONS. THE RV LEAD WAS NOT USED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252661 DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC SINGAPORE OPERATIONS 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR