BEUDAMED
    FDA Adverse Event Death Summary report: N

    KAPPA 900 DR

    MDR report key: 1662124 · Received April 20, 2010

    Report

    Report Number
    6000094-2010-00721
    Event Type
    Death
    Date Received
    April 20, 2010
    Date of Event
    January 5, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035/014
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    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. THERE WAS NO INDICATION THE DEATH WAS DEVICE RELATED; THE CAUSE OF DEATH HAS NOT YET BEEN DETERMINED. EVALUATION SUMMARY (B) (4) NO ANOMALIES FOUND.

    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. THERE WAS NO INDICATION THE DEATH WAS DEVICE RELATED; THE CAUSE OF DEATH HAS NOT YET BEEN DETERMINED.

    Description of Event or Problem · 1

    (B) (4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S DEVICE WAS INTERROGATED ON (B) (6) 2009 AND INDICATED A BATTERY LONGEVITY OF 5.5 YEARS. THE PATIENT EXPIRED APPROXIMATELY ONE MONTH LATER ((B) (6) 2010). A DEVICE INTERROGATION WAS PERFORMED AT THE AUTOPSY. THE DEVICE INTERROGATION REVEALED THE DEVICE HAD REACHED IT'S ESTIMATED REPLACEMENT INDICATOR (ERI) THREE DAY AFTER THE PATIENT'S DEATH. THERE ARE NO ALLEGATIONS FROM A HEALTHCARE PROFESSIONAL INDICATING THE DEATH IS DEVICE RELATED; HOWEVER, THE CAUSE OF DEATH HAS NOT BEEN DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAPPA 900 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. KDR903 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death UNK IMPLANTABLE PACING LEAD