BEUDAMED
    FDA Adverse Event Death Summary report: N

    TARGET TIP

    MDR report key: 2032959 · Received March 29, 2011

    Report

    Report Number
    2649622-2011-04266
    Event Type
    Death
    Date Received
    March 29, 2011
    Date of Event
    March 7, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K832099
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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.

    Additional Manufacturer Narrative · 1

    IT WAS FURTHER REPORTED BY THE PATIENT'S SPOUSE THAT PART OF THE RIGHT VENTRICULAR LEAD INSULATION BROKE OFF CAUSING A THROMBOSIS TO THE HEART AND THE PATIENT WENT DOWN HILL AFTER THAT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE 4012 LEAD WAS BEING USED IN THE RIGHT VENTRICULAR PORT AND THE DEVICE REPORTED A LEAD WARNING. THE LEADS WERE BEING EXTRACTED "TO MAKE ROOM FOR THE CRT-D IMPLANT." THE PATIENT DIED DURING THE LEAD EXTRACTION AND IS SCHEDULED FOR AN AUTOPSY. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP WITH THE PHYSICIAN REPORTED THE PATIENT HAD A POCKET INFECTION THAT WAS NOT DISCOVERED UNTIL THE LEAD EXTRACTION. THE PHYSICIAN DOES NOT HAVE THE EXACT CAUSE OF DEATH, BUT IS SUSPICIOUS THAT THE "INFECTION MAY HAVE PLAYED A ROLE."

    Description of Event or Problem · 1

    IT WAS REPORTED THE 4012 LEAD WAS BEING USED IN THE RIGHT VENTRICULAR PORT AND THE DEVICE REPORTED A LEAD WARNING. THE LEADS WERE BEING EXTRACTED "TO MAKE ROOM FOR THE CRT-D IMPLANT." THE PATIENT DIED DURING THE LEAD EXTRACTION AND IS SCHEDULED FOR AN AUTOPSY. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP WITH THE PHYSICIAN REPORTED THE PATIENT HAD A POCKET INFECTION THAT WAS NOT DISCOVERED UNTIL THE LEAD EXTRACTION. THE PHYSICIAN DOES NOT HAVE THE EXACT CAUSE OF DEATH, BUT IS SUSPICIOUS THAT THE "INFECTION MAY HAVE PLAYED A ROLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET TIP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4512 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death