BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 400 SR

    MDR report key: 2130321 · Received June 16, 2011

    Report

    Report Number
    2647346-2011-00863
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P970012
    Removal / Correction Number
    ASKU
    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. EVALUATION SUMMARY: (B)(4): ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ERI WAS LOGGED ON (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXHIBITED ELECTIVE REPLACEMENT INDICATORS (ERI), AND THE REP WAS UNABLE TO MEASURE THE REMAINING BATTERY DUE TO A SENSITIVITY INTERLOCK. THE REP WAS UNABLE TO REPROGRAM THE DEVICE TO TRY RE-MEASURING. THE DEVICE WAS EXPLANTED AND 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 400 SR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KSR401 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD