BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA 300 DR

    MDR report key: 3212715 · Received July 9, 2013

    Report

    Report Number
    3004209178-2013-11477
    Event Type
    Death
    Date Received
    July 9, 2013
    Report Date
    July 18, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE CAUSE OF DEATH AS CONGESTIVE HEART FAILURE, AORTIC STENOSIS AND DEMENTIA. FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS. THE CHANGE IS REFLECTED IN THIS REPORT UNDER - CONCLUSION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS BASED SOLELY ON DEVICE 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. PRODUCT EVENT SUMMARY: (B)(4) - 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. CONCOMITANT PRODUCTS: 4058M45 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 1995; 5024M-58 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 1995. (B)(4).

    Description of Event or Problem · 1

    THE IMPLANTABLE PULSE GENERATOR (IPG) WAS RETURNED WITH NO INFORMATION, ANALYZED AND TESTED OUT OF SPECIFICATION. FURTHER REVIEW OF THE MANUFACTURER¿S DATABASE INDICATED THE PATIENT IS DECEASED AND DIED APPROXIMATELY EIGHT YEARS POST IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313336 SIGMA 300 DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO SDR303B

    Patients

    Seq Age Sex Outcome Treatment
    1 00096 YR Death