BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA

    MDR report key: 2954856 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02053
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    December 14, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P970012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS FOUND TO BE AT ELECTIVE REPLACEMENT INDICATOR (ERI), AND THE RATE RESPONSE PARAMETERS WERE FOUND TO DISPLAY INVALID DATA. THE DEVICE WILL BE 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
    58250 KAPPA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO KSR401

    Patients

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