BEUDAMED
    FDA Adverse Event Death Summary report: N

    BP2 ABLATION DEVICE

    MDR report key: 873308 · Received June 25, 2007

    Report

    Report Number
    2135394-2007-00011
    Event Type
    Death
    Date Received
    June 25, 2007
    Report Date
    May 9, 2007
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    GEI
    PMA / PMN Number
    K031247
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: NO INFORMATION AVAILABLE. CONCLUSION: EXACT CAUSE OF THE EVENT CANNOT BE DETERMINED. EXHAUSTIVE ATTEMPTS TO OBTAIN THE DETAILS SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL, AS NEITHER THE SURGEON NOR HIS STAFF RECALL THE INFORMATION SURROUNDING THE EVENT. THE SURGEON HAD INDICATED, HOWEVER, THAT THE DEATH WAS NOT RELATED TO THE PERFORMANCE OF THE DEVICE, BUT THAT THE DEATH OCCURRED AS A RESULT OF THE SURGEON'S DECISION TO ABLATE IN THIS PATIENT WITH ENDOCARDITIS. A REVIEW OF COMPLAINTS HAS NOTED NO ADDITIONAL DEATH CASES. HOWEVER, MEDTRONIC CONTINUES TO MONITOR FIELD PERFORMANCE TO DETECT SIMILAR EVENTS, SHOULD THEY OCCUR.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED LIMITED INFORMATION THAT A PATIENT EXPIRED FOLLOWING THE USE OF THIS ABLATION DEVICE. THIS INFORMATION WAS OBTAINED FROM THE SURGEON. FOLLOW UP DISCUSSIONS WITH THE SURGEON AS WELL AS THE SURGEON'S STAFF INDICATES THAT THIS EVENT OCCURRED SOMETIME IN THE LAST YEAR (THE EXACT DATE WAS NOT KNOWN), AND THAT NEITHER PATIENT NOR DEVICE SPECIFIC INFORMATION COULD BE OBTAINED. THE SURGEON HAD STATED THAT THE PATIENT HAD ENDOCARDITIS, AND THAT IT WAS AN ERROR IN JUDGEMENT ON HIS PART TO ABLADE, GIVEN THE PATIENT'S STATUS. THE DETAILS ON THE EXACT CAUSE OF DEATH COULD NOT BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BP2 ABLATION DEVICE GEI MEDTRONIC PERFUSION SYSTEMS 60831 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death