BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 DR

    MDR report key: 1792660 · Received August 11, 2010

    Report

    Report Number
    6000144-2010-03196
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    April 26, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    Z-1510/1519-2009
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) PRELIMINARY TESTING REVEALED NO PACING OUTPUT WHEN DEVICE WAS PROGRAMMED DOO 60 BPM BIPOLAR MODE. TESTING ON THE AUTOMATED FUNCTIONAL TESTERS REVEALED ANOMALOUS OUTPUT CONDITIONS. THE NO OUTPUT CONDITION WAS THE RESULT OF LIFTED HYBRID BOND WIRES. ANALYSIS OF THE MEMORY DUMP DATA REVEALED THE DEVICE LEAD IMPEDANCE MEASURED OPEN ON (B)(6) 2010 WHICH IS THE SAME AS THE EXPLANT DATE.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    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 99 YR Other 4076 IMPLANTABLE PACING LEAD| 4092 IMPLANTABLE PACING LEAD