BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAPPA 900 VDD

    MDR report key: 2050653 · Received April 12, 2011

    Report

    Report Number
    6000094-2011-00473
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035/014
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    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) THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE MEMORY DATA FROM (B)(6) 2011. THE DEVICE'S GENERAL TIME/DATE CAPABILITIES ARE WORKING OK (POR TIME, IMPLANT TIME, DIAGNOSTIC START TIME, ETC.) THE VENTRICULAR HIGH RATE EPISODE (VHR) MEMORY DID NOT CHANGE FROM (B)(6) 2011. NEW EPISODE DATA IS NOT WRITING OVER SPECIFIC MEMORY LOCATIONS. THE PROGRAMMER IS NOT THE PROBLEM. THE PROGRAMMER IS JUST READING AND DECODING THE DATA IN THE DEVICE MEMORY. THE PROBLEM APPEARS TO BE ISOLATED IN THE MODESWITCH AND AHR EPISODE DIAGNOSTICS.

    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) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE MEMORY DATA FROM (B)(6) 2011 AND (B)(6) 2011. THE DEVICE'S GENERAL TIME/DATE CAPABILITIES ARE WORKING OK (POR TIME, IMPLANT TIME, DIAGNOSTIC START TIME, ETC.) THE VENTRICULAR HIGH RATE EPISODE (VHR) MEMORY DID NOT CHANGE FROM (B)(6) 2011. NEW EPISODE DATA IS NOT WRITING OVER SPECIFIC MEMORY LOCATIONS. THE PROGRAMMER IS NOT THE PROBLEM. THE PROGRAMMER IS JUST READING AND DECODING THE DATA IN THE DEVICE MEMORY. THE PROBLEM APPEARS TO BE ISOLATED IN THE MODESWITCH AND AHR EPISODE DIAGNOSTICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE DATE STAMP INCONSISTENCIES. IT WAS NOTED THAT THERE WAS INFORMATION IN THE DEVICE MEMORY THAT WAS BEING DISPLAYED AS EPISODE DATA; HOWEVER, THIS INFORMATION WAS DUE TO RANDOM MEMORY BIT PATTERNS THAT OCCURRED AT THE TIME OF MANUFACTURING AND THAT HAD NEVER BEEN REPLACED WITH TRUE EPISODE DATA. THE DEVICE REMAINED IN USED UNTIL IT WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE DATE STAMP INCONSISTENCIES. THE PULSE GENERATOR IS STILL IN USE. 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 900 VDD IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. KVDD901 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other