BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA 300 DR

    MDR report key: 1981071 · Received February 8, 2011

    Report

    Report Number
    6000144-2011-00014
    Event Type
    Death
    Date Received
    February 8, 2011
    Date of Event
    December 17, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) PRELIMINARY TESTING REVEALED THE DEVICE WAS AT ERI. TESTING REVEALED ANOMALOUS OUTPUT CONDITIONS. FURTHER TESTING REVEALED THE NO OUTPUT CONDITION WAS THE RESULT OF LIFTED HYBRID BOND WIRES. FURTHER TESTING REVEALED NO ANOMALIES FOUND AS DATE OF DEATH WAS (B)(6) 2010 AND ANALYSIS INDICATED THE DEVICE WAS FUNCTIONING UNTIL (B)(6) 2010, THREE DAYS AFTER THE DATE OF DEATH.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4) PRELIMINARY TESTING REVEALED THE DEVICE WAS AT ERI. TESTING REVEALED ANOMALOUS OUTPUT CONDITIONS. FURTHER TESTING REVEALED THE NO OUTPUT CONDITION WAS THE RESULT OF LIFTED HYBRID BOND WIRES.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO MANUFACTURER FOLLOWING PATIENT'S DEATH, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. THE CAUSE OF DEATH WAS REPORTED TO BE SEPSIS AND RENAL FAILURE. ADDITIONAL INFORMATION WILL BE REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD