BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SENSE

    MDR report key: 1921391 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12501
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 3, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S034
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    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.

    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. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED THAT THERE IS NO RECORD OF PROGRAMMING HISTORY OF THE POLARITY WITHIN THE MEMORY DUMP FILE, AND THUS THE COMPLAINT CANNOT BE CONFIRMED THROUGH SAVE-TO-DISK ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CHANGE OUT OF THE DEVICE, THE LEAD CONFIGURATION CONVERTED TO UNIPOLAR AFTER THE LEAD WAS INSERTED IN THE HEADER. THE LEAD 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 CAPSURE SENSE IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4074 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other (B)(4) IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR