BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 SR

    MDR report key: 1874623 · Received October 19, 2010

    Report

    Report Number
    6000144-2010-05393
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    August 18, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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.

    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 DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A FAILURE TO CAPTURE AND HIGH RESISTANCE ON THE RIGHT VENTRICULAR LEAD. THE RIGHT VENTRICULAR LEAD WAS CAPPED AND REPLACED. THE DEVICE WAS EXPLANTED AND REPLACED DUE TO NO CAPTURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A FAILURE TO CAPTURE AND HIGH RESISTANCE ON THE RIGHT VENTRICULAR LEAD. THE RIGHT VENTRICULAR LEAD WAS CAPPED AND REPLACED. UPON FURTHER REVIEW IT WAS REPORTED THAT THE LEAD HAD FRACTURED. THE DEVICE WAS EXPLANTED AND REPLACED DUE TO NO CAPTURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. LEAD FRACTURE ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 300 SR ASKU DXY MEDTRONIC MED REL, INC. SSR303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R