BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA 300 DR

    MDR report key: 1901719 · Received November 17, 2010

    Report

    Report Number
    6000094-2010-02133
    Event Type
    Death
    Date Received
    November 17, 2010
    Date of Event
    December 18, 2007
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) NO ANOMALIES WERE FOUND. (B)(4) NO ANOMALIES FOUND; THE FULL LEAD WAS RETURNED FOR ANALYSIS. ALL INSULATORS WERE BREACHED/CUT, THE OUTER INSULATION HAD COSMETIC DEPRESSIONS AND BLOOD WAS OBSERVED IN/ON THE HELIX MECHANISM. THERE WAS APPARENT EXPLANT DAMAGE. (B)(4) NO ANOMALIES FOUND; THE FULL LEAD WAS RETURNED FOR ANALYSIS. THE PROXIMAL CONDUCTOR WAS DISTORTED, THE OUTER INSULATION WAS BREACHED/CUT, AND BLOOD WAS OBSERVED IN/ON THE HELIX MECHANISM. THERE WAS APPARENT EXPLANT DAMAGE AND THE LEAD WAS STRETCHED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) NO ANOMALIES WERE FOUND. (B)(4) NO ANOMALIES FOUND; THE FULL LEAD WAS RETURNED FOR ANALYSIS. ALL INSULATORS WERE BREACHED/CUT, THE OUTER INSULATION HAD COSMETIC DEPRESSIONS AND BLOOD WAS OBSERVED IN/ON THE HELIX MECHANISM. THERE WAS APPARENT EXPLANT DAMAGE. (B)(4) NO ANOMALIES FOUND; THE FULL LEAD WAS RETURNED FOR ANALYSIS. THE PROXIMAL CONDUCTOR WAS DISTORTED, THE OUTER INSULATION WAS BREACHED/CUT, AND BLOOD WAS OBSERVED IN/ON THE HELIX MECHANISM. THERE WAS APPARENT EXPLANT DAMAGE AND THE LEAD WAS STRETCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED LESS THAN 7 MONTHS AFTER DEVICE WAS IMPLANTED. FOLLOW UP WITH HOSPITAL REVEALED PATIENT LAST SEEN BY THEM DUE TO BREAKING HIP FROM FALL. NO DEVICE ISSUES WERE REPORTED. THE CAUSE OF DEATH WAS INTRAPARENCHYMAL HEMORRHAGE INCURRED AFTER FALL. THERE WERE NO DEVICE ALLEGATIONS FROM THE HEALTH CARE PROFESSIONAL .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED LESS THAN 7 MONTHS AFTER DEVICE WAS IMPLANTED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 300 DR ASKU DXY MEDTRONIC S.A. SDR303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death