BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 DR

    MDR report key: 2813221 · Received October 31, 2012

    Report

    Report Number
    2647346-2012-01764
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    Z-1516-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH 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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IN-OFFICE DEVICE CHECK, THERE WAS NO OUTPUT AND NO TELEMETRY WITH TWO DIFFERENT PROGRAMMERS. THERE WAS ALSO NO MAGNET RESPONSE ON THE ELECTROCARDIOGRAM. THE PREVIOUS REMOTE TRANSMISSION WAS REVIEWED AND IT SHOWED NO PACING, HOWEVER, THIS HAD NOT BEEN DETECTED AT THE TIME. AT THE PREVIOUS OFFICE VISIT THREE MONTHS PRIOR, THE BATTERY LONGEVITY ESTIMATE WAS 2.5 YEARS. THE DEVICE WILL BE SCHEDULED FOR CHANGEOUT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THE DEVICE WAS AT ERI AND WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 300 DR PULSE GENERATOR, PERMANENT, IMPLANTABLE DXY MEDTRONIC MED REL, INC. SDR303

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 1388TC COMPETITOR IMPLANTABLE PACING LEAD