BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAPPA 900 SR

    MDR report key: 1971234 · Received January 26, 2011

    Report

    Report Number
    2647346-2011-00046
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/014
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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

    ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): PRELIMINARY ANALYSIS REVEALED NO OUTPUT AND NO TELEMETRY. FURTHER TESTING REVEALED THAT THE NO OUTPUT AND NO TELEMETRY CONDITIONS WERE THE RESULT OF LIFTED HYBRID BOND WIRES. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TELEMETRY WITH THE DEVICE WAS UNABLE TO BE ESTABLISHED, AND NO PACING WITH THE MAGNET WAS POSSIBLE. IT WAS FURTHER REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT TELEMETRY WITH THE DEVICE WAS UNABLE TO BE ESTABLISHED, AND NO PACING WITH THE MAGNET WAS POSSIBLE. IT WAS FURTHER REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT DURING THE OFFICE VISIT THE DEVICE YIELDED NO TELEMETRY, AND THE BATTERY HAD BEEN COMPLETELY DEPLETED AND HAD NO OUTPUT. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TELEMETRY WITH THE DEVICE WAS UNABLE TO BE ESTABLISHED, AND NO PACING WITH THE MAGNET WAS POSSIBLE. IT WAS FURTHER REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TELEMETRY WITH THE DEVICE WAS UNABLE TO BE ESTABLISHED, AND NO PACING WITH THE MAGNET WAS POSSIBLE. IT WAS FURTHER REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT DURING THE OFFICE VISIT THE DEVICE YIELDED NO TELEMETRY, AND THE BATTERY HAD BEEN COMPLETELY DEPLETED AND HAD NO OUTPUT. 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 900 SR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KSR901 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization| O| R 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD