BEUDAMED
    FDA Adverse Event Summary report: N

    KAPPA 700 DR

    MDR report key: 1792325 · Received August 10, 2010

    Report

    Report Number
    2647346-2010-00363
    Date Received
    August 10, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035
    Removal / Correction Number
    Z-1510/1519-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) PRELIMINARY ANALYSIS REVEALED NO TELEMETRY AND NO OUTPUT. FURTHER TESTING REVEALED THE NO TELEMETRY AND NO OUTPUT CONDITIONS WERE THE RESULT OF LIFTED HYBRID BOND WIRES.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. CORRECTED FDA ACT. #. EVALUATION SUMMARY: (B)(4) PRELIMINARY ANALYSIS REVEALED NO TELEMETRY AND NO OUTPUT. FURTHER TESTING REVEALED THE NO TELEMETRY AND NO OUTPUT CONDITIONS WERE THE RESULT OF LIFTED HYBRID BOND WIRES.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR ANALYSIS AFTER BEING EXPLANTED DUE TO ELECTIVE REPLACEMENT INDICATOR. THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. 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 700 DR ASKU DXY MEDTRONIC MED REL, INC. KDR701 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 4592 IMPLANTABLE PACING LEAD| 4092 IMPLANTABLE PACING LEAD| 4592 IMPLANTABLE PACING LEAD| 4092 IMPLANTABLE PACING LEAD