BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN OTW

    MDR report key: 2071191 · Received April 27, 2011

    Report

    Report Number
    2649622-2011-07339
    Event Type
    Death
    Date Received
    April 27, 2011
    Date of Event
    March 30, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HOSPITAL INDICATES THE PATIENT HAD NOTICED AN INCREASE IN IRRITATION AROUND HER DEVICE AND HAD STARTED COMING THROUGH HER SKIN. DURING THE PROCEDURE TO REMOVE THE DEVICE SYSTEM, AS SUCH EROSIONS ARE CONSIDERED INFECTION, THE PATIENT UNDERWENT LASER LEAD EXTRACTION WHICH RESULTED IN THE PATIENT DEATH DUE TO INNOMINATE VEIN PERFORATION. RESUSCITATION EFFORTS WERE UNSUCCESSFUL. 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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA AND NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HOSPITAL INDICATES THE PATIENT HAD NOTICED AN INCREASE IN IRRITATION AROUND HER DEVICE AND HAD STARTED COMING THROUGH HER SKIN. DURING THE PROCEDURE TO REMOVE THE DEVICE SYSTEM, AS SUCH EROSIONS ARE CONSIDERED INFECTION, THE PATIENT UNDERWENT LASER LEAD EXTRACTION WHICH RESULTED IN THE PATIENT DEATH DUE TO INNOMINATE VEIN PERFORATION. RESUSCITATION EFFORTS WERE UNSUCCESSFUL. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SYSTEM WAS BEING EXPLANTED DUE TO INFECTION. THE DEVICE AND ONE LEAD HAD BEEN REMOVED WHEN THE PATIENT BEGAN DECOMPENSATING AND FURTHER EXTRACTION OF REMAINING LEADS WAS ABANDONED. THE PATIENT DIED DURING THE PROCEDURE. FOLLOW UP INFORMATION OBTAINED FROM THE MANUFACTURER'S REPRESENTATIVE INDICATED THAT IT WAS REPORTED THAT THERE WAS A PERFORATION. ADDITIONAL INFORMATION REGARDING THE PROCEDURE HAS BEEN REQUESTED BUT NOT RECEIVED.

    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 78 YR Death| H| L| R