BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 700 DR

    MDR report key: 1863021 · Received October 9, 2010

    Report

    Report Number
    2647346-2010-00640
    Event Type
    Injury
    Date Received
    October 9, 2010
    Date of Event
    August 9, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035
    Removal / Correction Number
    Z-2120-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. ADDITIONAL INFORMATION: THE DEVICE WAS RECEIVED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. EVALUATION SUMMARY: (B)(4) - THE DEVICE WAS RETURNED TO THE MANUFACTURER AND ANALYZED. THE DEVICE EXPERIENCED NORMAL DEPLETION AND MET EXPECTED LONGEVITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE INTERROGATED AND THE DEVICE WAS PRESUMED TO BE AT END OF SERVICE. THE DEVICE WAS REPLACED. 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 IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KDR701 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention 4024 IMPLANTABLE PACING LEAD| 4524 IMPLANTABLE PACING LEAD| 4024 IMPLANTABLE PACING LEAD| 4524 IMPLANTABLE PACING LEAD