BEUDAMED
    FDA Adverse Event Death Summary report: N

    KAPPA 900 SR

    MDR report key: 3151339 · Received June 7, 2013

    Report

    Report Number
    9614453-2013-01073
    Event Type
    Death
    Date Received
    June 7, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 15, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DXY
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) - THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE INDICATED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE ASSOCIATED WITH THIS ADVERSE OUTCOME WERE RETURNED AND THE PATIENT WAS REPORTED AS BEING DECEASED WITH NO CAUSE OF DEATH. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. HOWEVER, IF ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. NO FURTHER INFORMATION HAS BEEN OBTAINED AT THIS TIME THAT COULD OR WOULD DISASSOCIATE THE DEATH FROM THE DEVICE SYSTEM AND/OR THE DEATH. THEREFORE THIS EVENT WILL BE PROCESSED WITH THE INFORMATION AT HAND AND WILL BE CAPTURED AS A MEDICAL/DEATH ON INCOMING INFORMATION. (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORT INDICATED THAT IT WAS UNDECIDED IF THE DEVICE WAS SUSPECTED IN RELATIONSHIP TO THE DEATH.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE AND THE ATTEMPT FOR ADDITIONAL INFORMATION THROUGH FOLLOW UP FROM THE LOCAL GEOGRAPHY WAS UNSUCCESSFUL. THE CAUSE OF DEATH WAS REPORTED AS UNKNOWN AND REMAINS AS UNKNOWN. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPLANTABLE PULSE GENERATOR COLLAPSED DURING A FIELD TRIP AND WAS PRONOUNCED DECEASED. IT WAS ALSO NOTED THAT THE IPG REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) APPROXIMATELY 22 DAYS PRIOR TO THE DEATH. THE DEATH WAS REPORTED AS SUDDEN AND THE CAUSE OF DEATH IS REPORTED AS UNKNOWN. THE PATIENT DIED APPROXIMATELY SEVEN YEARS POST IMPLANT OF THE IPG.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPLANTABLE PULSE GENERATOR COLLAPSED DURING A FIELD TRIP AND WAS PRONOUNCED DECEASED. IT WAS ALSO NOTED THAT THE IPG REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) 22 DAYS PRIOR TO THE DEATH. THE DEATH WAS REPORTED AS SUDDEN AND THE CAUSE OF DEATH IS REPORTED AS UNKNOWN. THE PATIENT DIED APPROXIMATELY SEVEN YEARS POST IMPLANT OF THE IPG.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPLANTABLE PULSE GENERATOR COLLAPSED DURING A FIELD TRIP AND WAS PRONOUNCED DECEASED. IT WAS ALSO NOTED THAT THE IPG REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) TWO DAYS PRIOR TO THE DEATH. THE DEATH WAS REPORTED AS SUDDEN AND THE CAUSE OF DEATH IS REPORTED AS UNKNOWN. THE PATIENT DIED APPROXIMATELY SEVEN YEARS POST IMPLANT OF THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253349 KAPPA 900 SR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY IPG MFG SWITZERLAND KSR903

    Patients

    Seq Age Sex Outcome Treatment
    1 00012 YR Death 4470 COMPETITOR PACING LEAD