BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 1913386 · Received December 3, 2010

    Report

    Report Number
    2649622-2010-12201
    Event Type
    Death
    Date Received
    December 3, 2010
    Date of Event
    October 24, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    Z0474-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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 FOUND. (B)(4) NO ANOMALIES FOUND, OUTER INSULATION DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    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). 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 THERE WAS OUTER INSULATION DEPRESSION AND VISUAL ANALYSIS 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. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4). NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED APPROXIMATELY SEVEN MONTHS AFTER A DEVICE AND LEAD IMPLANT. THE CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED. BASED ON FOLLOW-UP RECEIVED, APPROXIMATELY TWO MONTHS PRIOR TO THE PATIENT'S DEATH, THE PATIENT HAD BEEN SEEN FOR A DEVICE CHECK AND IT REVEALED THE PATIENT HAD ONE NONSUSTAINED VENTRICULAR TACHYCARDIA AND ONE SHOCK FOR VENTRICULAR FIBRILLATION. IT WAS NOTED IN THE HOSPITAL MEDICAL RECORDS THAT THE PATIENT WAS DISCHARGED APPROXIMATELY ONE MONTH PRIOR TO THE PATIENT'S DEATH WITH INSTRUCTIONS TO FOLLOW-UP WITH THE PATIENT'S PHYSICIAN FOR A STATUS POST CHECK RELATING TO A RIGHT PLEURAL EFFUSION. THE PHYSICIAN'S OFFICE HAD NO INFORMATION REGARDING THE PATIENT SINCE THE LAST OFFICE VISIT AND WAS ONLY AWARE OF THE PATIENT'S DEATH AND NO FURTHER INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED APPROXIMATELY SEVEN MONTHS AFTER A DEVICE AND LEAD IMPLANT. THE CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| H| R