BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 900 DR

    MDR report key: 1922682 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05971
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/014
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. EVALUATION SUMMARY: (B)(4): BATTERY DEPLETION WAS NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POCKET REVISION DUE TO ERODED STITCHES. THE DEVICE WAS REPLACED BECAUSE IT WAS NEARING ERI. 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 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KDR901 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R 5076 X2 IMPLANTABLE PACING LEAD