BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN OTW

    MDR report key: 1813569 · Received August 25, 2010

    Report

    Report Number
    2649622-2010-08899
    Event Type
    Death
    Date Received
    August 25, 2010
    Date of Event
    December 16, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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) THE FULL LEAD WAS RETURNED AND ANALYZED. PRIMARY ANALYSIS FINDING: NO ANOMALIES FOUND. BLOOD/BODY FLUID WAS PRESENT IN DISTAL CONDUCTOR AT ELECTRODE END (NOT OBSTRUCTED). AT THE TIME OF THE RETRO REVIEW, IT WAS NOTED IN THE MANUFACTURER'S DATABASE THAT THE PATIENT HAD DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    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 FULL LEAD WAS RETURNED AND ANALYZED. PRIMARY ANALYSIS FINDING: NO ANOMALIES FOUND. BLOOD/BODY FLUID WAS PRESENT IN DISTAL CONDUCTOR AT ELECTRODE END (NOT OBSTRUCTED). AT THE TIME OF THE RETRO REVIEW, IT WAS NOTED IN THE MANUFACTURER'S DATABASE THAT THE PATIENT HAD DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    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 FULL LEAD WAS RETURNED AND ANALYZED. PRIMARY ANALYSIS FINDING: NO ANOMALIES FOUND. BLOOD/BODY FLUID WAS PRESENT IN DISTAL CONDUCTOR AT ELECTRODE END (NOT OBSTRUCTED). AT THE TIME OF THE RETRO REVIEW, IT WAS NOTED IN THE MANUFACTURER'S DATABASE THAT THE PATIENT HAD DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SEVEN DAYS POST IMPLANT, THE LEFT VENTRICULAR LEAD DISLODGED. CONSEQUENTLY, IT WAS REMOVED AND REPLACED WITH AN ACTIVE FIXATION LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. LATER REVIEW OF MANUFACTURER'S DATABASE REVELED THE PATIENT HAD DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SEVEN DAYS POST IMPLANT, THE LEFT VENTRICULAR LEAD DISLODGED. CONSEQUENTLY, IT WAS REMOVED AND REPLACED WITH AN ACTIVE FIXATION LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. LATER REVIEW OF MANUFACTURER'S DATABASE REVELED THE PATIENT HAD DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP REVEALED THE LAST TIME PATIENT WAS SEEN IN THE CLINIC WAS (B)(6) 2009 WITH WOUND CHECK AND DEVICE PARAMETERS REPORTED TO BE FINE. THE PATIENT WAS BEING PACED 100%. FOLLOW UP REVEALED PATIENT WAS HOSPITALIZED FOR CHF WITH 50 POUND WEIGHT GAIN (B)(6) 2009 - (B)(6) 2010. MEDICATION ADJUSTMENTS AND REPROGRAMMING OF DEVICE DONE DURING HOSPITAL STAY. PATIENT HAD BEEN REPORTED TO BE DOING WELL AT THE CARE CENTER DOING 30 MINUTES OF EXERCISE WITH CHEST PAIN OR SHORTNESS OF BREATH AND NO DEVICE THERAPIES DELIVERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SEVEN DAYS POST IMPLANT, THE LEFT VENTRICULAR LEAD DISLODGED. CONSEQUENTLY, IT WAS REMOVED AND REPLACED WITH AN ACTIVE FIXATION LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. LATER REVIEW OF MANUFACTURER'S DATABASE REVELED THE PATIENT HAD DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP REVEALED THE LAST TIME PATIENT WAS SEEN IN THE CLINIC WAS (B)(6) 2009 WITH WOUND CHECK AND DEVICE PARAMETERS REPORTED TO BE FINE. THE PATIENT WAS BEING PACED 100%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW ASKU DTB MEDTRONIC PUERTO RICO, INC. 4194 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| H| L| R 4196 IMPLANTABLE PACING LEAD| 7120 COMPETITOR IMPLANTABLE TACHY LEAD| (B)(4) COMPTETITOR IMPLANTABLE PACING LEAD| (B)(4) COMPTETITOR IMPLANTABLE PACING LEAD| 4196 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7120 COMPETITOR IMPLANTABLE TACHY LEAD