BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENPULSE

    MDR report key: 1981075 · Received February 8, 2011

    Report

    Report Number
    6000094-2011-00021
    Event Type
    Death
    Date Received
    February 8, 2011
    Date of Event
    December 12, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S030
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4) : THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT ALL CONDUCTORS DISTORTED, THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION WAS BREACHED CUT AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4) THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DEVICE AND LEAD ARE IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT ALL CONDUCTORS DISTORTED, THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION WAS BREACHED CUT AND THERE WAS APPARENT EXPLANT DAMAGE. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED BY A MEDICAL EXAMINER THAT A PATIENT DIED OF UNKNOWN CAUSES WITH A HISTORY OF SEVERE ARTERIOSCLEROTIC HEART DISEASE. TOXICOLOGY RESULTS ARE PENDING AND A REQUEST FOR THE INFORMATION HAS BEEN MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENPULSE IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. E2SR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death