BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN OTW

    MDR report key: 2020996 · Received March 16, 2011

    Report

    Report Number
    2649622-2011-03922
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    June 12, 2006
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. LEAD MODEL 6949 IS PART OF THE ADVISORY. ANALYSIS OF THE DEVICE ((B)(4)) IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THAT VISUAL ANALYSIS WAS PERFORMED ONLY. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THAT VISUAL ANALYSIS WAS PERFORMED ONLY. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THAT VISUAL ANALYSIS WAS PERFORMED ONLY.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. LEAD MODEL 6949 IS PART OF THE ADVISORY. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THAT VISUAL ANALYSIS WAS PERFORMED ONLY. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THAT VISUAL ANALYSIS WAS PERFORMED ONLY. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THAT VISUAL ANALYSIS WAS PERFORMED ONLY.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    AN ALLEGATION FROM AN ATTORNEY INDICATED PATIENT SUSTAINED INJURIES AS A "RESULT OF A DEFECTIVE PRODUCT". APPROXIMATELY FOUR MONTHS LATER, AN ALLEGATION FROM A SECOND ATTORNEY INDICATED THE PATIENT "SUFFERED PHYSICAL AND OTHER INJURY AS A RESULT OF THE RECALLED LEAD" AND "DIED AS A DIRECT AND PROXIMATE RESULT OF DEFECTS" OF THE LEAD. PATIENT "SUFFERED BODILY INJURY AND RESULTING PAIN AND SUFFERING, DISABILITY, DISFIGUREMENT, MENTAL ANGUISH, LOSS OF CAPACITY OF THE ENJOYMENT OF LIFE, SHORTENED LIFE EXPECTANCY, EXPENSES OF HOSPITALIZATION, MEDICAL AND NURSING CARE AND TREATMENT, MONITORING, AND LOSS OF EARNINGS" PRIOR TO THE PATIENT'S DEATH. PATIENT "SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH, ECONOMIC LOSSES AND OTHER DAMAGES". APPROXIMATELY TWO YEARS LATER, AN ALLEGATION FROM A THIRD ATTORNEY INDICATED THE PATIENT IS DECEASED AND FURTHER NOTED "DEATH ASSOCIATED WITH EXPLANT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4194 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death| H| L| O| R| S