BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1973177 · Received January 28, 2011

    Report

    Report Number
    2649622-2011-00146
    Event Type
    Death
    Date Received
    January 28, 2011
    Date of Event
    January 4, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S27
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4) OUTER INSULATION BREACHED AND COSMETIC ESC AND COSMETIC MIO. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO MANFACTURER FOLLOWING THE PATIENT'S DEATH, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO MANUFACTURER FOLLOWING THE PATIENT'S DEATH, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. FOLLOW UP NOTED DISCHARGE SUMMARY FROM HOSPITAL REPORTS PATIENT WAS ADMITTED TO THE HOSPITAL 13 DAYS PRIOR TO PATIENT DEATH. CAUSE OF DEATH WAS CONGESTIVE HEART FAILURE, CHRONIC RENAL FAILURE, PNEUMONIA, RESPIRATORY FAILURE, SEPSIS. PATIENT ALSO HAD CHRONIC OBSTRUCTIVE PULMONARY DISEASE WITH A TRACHEOTOMY AND WAS POSITIVE FOR PSEUDOMONAS INFECTION. THE DISCHARGE SUMMARY DID NOT STATE THAT THE DEVICE AND/OR LEADS WERE IMPLICATED IN THE PATIENT'S DEATH. ALSO THERE WAS NO MENTION OF ANY PROBLEMS WITH THE DEVICE OR LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4592 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death 4092 IMPLANTABLE PACING LEAD| 4092 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) IMPLANTABLE PULSE GENERATOR