BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 700 SR

    MDR report key: 1841928 · Received September 23, 2010

    Report

    Report Number
    2647346-2010-00527
    Event Type
    Injury
    Date Received
    September 23, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035
    Removal / Correction Number
    ASKU
    Adverse Event
    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) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. BATTERY DEPLETION INDICATED/ERI - WENT TO ERI ON (B)(6) 2009.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS AT ERI, AND THAT WHEN IT WAS INTERROGATED, ONLY QUESTION MARKS WOULD APPEAR BY THE SENSING VALUE. THE SENSIVITY SETTING WAS ABLE TO BE PROGRAMMED AND INTERROGATION COULD PROCEED. THE DEVICE WAS EXPLANTED AND REPLACED. FOLLOW UP REVEALED THAT WHILE AT THE DENTIST OFFICE A FEW WEEKS BEFORE DEVICE REPLACED, MAGNET WAS PLACED OVER THE DEVICE, PATIENT WENT INTO SVT, AND "THAT LED TO A DEVICE CHECK WHERE THEY DISCOVERED THE NEED FOR A GENERATOR CHANGE." THE PATIENT WAS REPORTED TO BE PACEMAKER DEPENDENT, THOUGH DID HAVE HER OWN UNDERLYING RHYTHM IN THE 80S TO 90S. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAPPA 700 SR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KSR701 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention UNKNOWN IMPLANTABLE PACING LEAD| 4968 IMPLANTABLE PACING LEAD