BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA 300 SR

    MDR report key: 1953064 · Received January 7, 2011

    Report

    Report Number
    6000144-2011-00003
    Event Type
    Death
    Date Received
    January 7, 2011
    Date of Event
    September 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
    MN, 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. THIS INFORMATION WAS RECEIVED FROM A COMPETITOR. ALL DATA PERTINENT TO THE EVENT IS PROVIDED. THE INITIAL REPORTABLE EVENT WAS RECEIVED ON (B)(4) 2010. OF NOTE, THE REPORTABLE MALFUNCTION IS NORMALLY SUBMITTED VIA A BIMONTHLY MEDWATCH REPORT SUBMISSION THAT WOULD HAVE BEEN DUE ON 2/10/2011. INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(4) 2010 AND REVEALED PATIENT DIED. AS THERE IS NEW INFORMATION THAT REASONABLY SUGGESTS THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, THIS EVENT NO LONGER QUALIFIES FOR BIMONTHLY REPORTING AND IS THEREFORE BEING SUBMITTED AS A 30-DAY REPORT. EVALUATION SUMMARY (B)(4) PRELIMINARY TESTING REVEALED NO PACING OUTPUT. THE NO OUTPUT CONDITION WAS THE RESULT OF LIFTED HYBRID BOND WIRES. ANALYSIS OF THE MEMORY DUMP WAS INCONCLUSIVE IF THERE WERE WIRE BOND LIFTS BEFORE OR AFTER EXPLANT BECAUSE THE EXPLANT DATE IS NOT AVAILABLE.

    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. THIS INFORMATION WAS RECEIVED FROM A COMPETITOR. ALL DATA PERTINENT TO THE EVENT IS PROVIDED. THE INITIAL REPORTABLE EVENT WAS RECEIVED ON (B)(6) 2010. OF NOTE, THE REPORTABLE MALFUNCTION IS NORMALLY SUBMITTED VIA A BIMONTHLY MEDWATCH REPORT SUBMISSION THAT WOULD HAVE BEEN DUE ON (B)(6) 2011. INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(6) 2010 AND REVEALED PATIENT DIED. AS THERE IS NEW INFORMATION THAT REASONABLY SUGGESTS THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, THIS EVENT NO LONGER QUALIFIES FOR BIMONTHLY REPORTING AND IS THEREFORE BEING SUBMITTED AS A 30-DAY REPORT. EVALUATION SUMMARY (B)(4) PRELIMINARY TESTING REVEALED NO PACING OUTPUT. THE NO OUTPUT CONDITION WAS THE RESULT OF LIFTED HYBRID BOND WIRES. ANALYSIS OF THE MEMORY DUMP WAS INCONCLUSIVE IF THERE WERE WIRE BOND LIFTS BEFORE OR AFTER EXPLANT BECAUSE THE EXPLANT DATE IS NOT AVAILABLE.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. FOLLOW UP WITH THE CLINIC LATER DETERMINED THE PATIENT HAD DIED AFTER GOING TO HOSPICE. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. FOLLOW UP WITH THE CLINIC LATER DETERMINED THE PATIENT HAD DIED AFTER GOING TO HOSPICE. FOLLOW UP REVEALED THAT PER THE DEATH CERTIFICATE, THE CAUSE OF DEATH WAS CARDIO RESPIRATORY ARREST, THE UNDERLYING CAUSE BEING CONGESTIVE HEART FAILURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death 5024M IMPLANTABLE PACING LEAD| 5024M IMPLANTABLE PACING LEAD| 5024M IMPLANTABLE PACING LEAD