BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL XT

    MDR report key: 1791926 · Received August 10, 2010

    Report

    Report Number
    6000144-2010-03114
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K071641
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): PERFORMANCE DATA COLLECTED FROM THE DEVICE REVEALED A POTENTIAL DATA RECORDING PROBLEM. THE DEVICE WAS LATER RETURNED AND ANALYZED. THE RECORDING PROBLEM WAS THE RESULT OF A SOLDER SHORT ON THE HYBRID.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 DATA. REVIEW OF THE DATA REVEALED A POTENTIAL DATA RECORDING PROBLEM. THE DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FALSE ASYSTOLE EPISODE WAS RECORDED AND THAT THERE WAS UNDERSENSING. IT WAS FURTHER REPORTED THAT THERE WAS ONLY TEXT FOR TWO EPISODES, AND THAT THERE WAS UNDERSENSING. IT WAS FURTHER REPORTED THAT THERE WAS AN APPARENT MEMORY PROBLEM WITH THE DEVICE. FURTHER REPORT OF CARELINK EPISODE DATA SHOWING SEVERAL "INVALID DATA" WITH ??? EPISODES. THE DEVICE WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THE DEVICE WAS ELECTIVELY REMOVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FALSE ASYSTOLE EPISODE WAS RECORDED AND THAT THERE WAS UNDERSENSING. IT WAS FURTHER REPORTED THAT THERE WAS ONLY TEXT FOR TWO EPISODES, AND THAT THERE WAS UNDERSENSING. IT WAS FURTHER REPORTED THAT THERE WAS AN APPARENT MEMORY PROBLEM WITH THE DEVICE. FURTHER REPORT OF CARELINK EPISODE DATA SHOWING SEVERAL "INVALID DATA" WITH EPISODES. THE DEVICE REMAINS 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 REVEAL XT ASKU DSI MEDTRONIC MED REL, INC. 9529 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| O| R