BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA 200 SR

    MDR report key: 1841929 · Received September 23, 2010

    Report

    Report Number
    6000144-2010-04265
    Event Type
    Death
    Date Received
    September 23, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    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. INFORMATION SUBSEQUENTLY RECEIVED ON 9/21/2010 REVEALED THE PATIENT HAD DIED. OF NOTE, THE REPORTABLE MALFUNCTION IS NORMALLY SUBMITTED VIA A (B)(4) MEDWATCH REPORT SUBMISSION THAT WOULD HAVE BEEN DUE ON 10/10/2010. HOWEVER, AS THERE IS NOW INFORMATION THAT REASONABLY SUGGESTS THAT THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, THIS NOW REQUIRES SUBMISSION AS A 30-DAY REPORT. EVALUATION SUMMARY (B)(4) PRELIMINARY ANALYSIS REVEALED THE DEVICE WAS AT ERI AND PROGRAMMED TO VVI 65 BPM BIPOLAR MODE. TESTING REVEALED ANOMALOUS OUTPUT CONDITIONS. FURTHER TESTING REVEALED THAT THE NO OUTPUT CONDITION WAS THE RESULT OF LIFTED HYBRID BOND WIRES.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. FOLLOW UP REVEALED THE PATIENT HAD DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 200 SR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. SSR203 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 4076 IMPLANTABLE PACING LEAD