BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 400 DR

    MDR report key: 1990139 · Received February 15, 2011

    Report

    Report Number
    6000094-2011-00206
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    November 1, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P970012
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4): ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE TIP ELECTRODE WAS PULLED OUT/OFF, ALL CONDUCTORS ARE STRETCHED, THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS APPARENT EXPLANT DAMAGE AND THE LEAD WAS STRETCHED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) DEVICE WAS NOT ANALYZED AS IT REACHED IT'S EXPECTED LONGEVITY. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE TIP ELECTRODE WAS PULLED OUT/OFF, ALL CONDUCTORS ARE STRETCHED, THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS APPARENT EXPLANT DAMAGE AND THE LEAD WAS STRETCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR LEAD WAS PRODUCING AN ARTIFACT ("A SPIKE") PERIODICALLY AFTER ATRIAL SENSED EVENTS, AND IT WAS ALSO OBSERVED THERE WAS A VENTRICULAR PACE WHICH DID NOT CAPTURE. THE LEAD WAS REMOVED AND REPLACED. IT WAS ALSO REPORTED THAT WHILE IN THE PROCEDURE FOR THE LEAD REVISION THE "HEADER BLOCK FELT SOFT" ON THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR LEAD WAS PRODUCING AN ARTIFACT ("A SPIKE") PERIODICALLY AFTER ATRIAL SENSED EVENTS, AND IT WAS ALSO OBSERVED THERE WAS A VENTRICULAR PACE WHICH DID NOT CAPTURE. THE LEAD WAS REMOVED AND REPLACED. IT WAS ALSO REPORTED THAT WHILE IN THE PROCEDURE FOR THE LEAD REVISION THE "HEADER BLOCK FELT SOFT" ON THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAPPA 400 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. KDR401 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R