BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 1914538 · Received December 3, 2010

    Report

    Report Number
    2649622-2010-12214
    Event Type
    Death
    Date Received
    December 3, 2010
    Date of Event
    December 9, 2003
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    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 FOUND. (B)(4) NO ANOMALIES FOUND. 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) NO ANOMALIES FOUND. (B)(4) NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED 8 DAYS AFTER DEVICE IMPLANT. FOLLOW UP REVEALED THE DEATH DISCHARGE SUMMARY FROM THE HOSPITAL NOTES THE FINAL DIAGNOSIS WERE GANGRENOUS LOWER EXTREMITY SECONDARY TO ARTERIAL INSUFFICIENCY WITH AMPUTATION; RENAL FAILURE SECONDARY TO SEVERE CONGESTIVE HEART FAILURE AND POSTOP STATE; SEVERE CARDIOMYOPATHY WITH CONGESTIVE HEART FAILURE; DIABETES MELLITUS; ATRIAL FIBRILLATION WITH PAUSES FOR WHICH HE RECEIVED A PACEMAKER; (B)(6) INFECTION OF LOWER EXTREMITIES; ACUTE PULMONARY EMBOLISM POSTOP. NO MENTION OF ANY DEVICE PERFORMANCE CONCERNS AFTER IMPLANT. PATIENT CONDITION DETERIORATED AND WAS MADE DO NOT RESUSUITATE PER FAMILY PRIOR TO HIS DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED 8 DAYS AFTER DEVICE IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE Z NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5054 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death