BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN OTW

    MDR report key: 1792260 · Received August 10, 2010

    Report

    Report Number
    2649622-2010-07066
    Event Type
    Death
    Date Received
    August 10, 2010
    Date of Event
    May 3, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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

    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. OVERSENSING - MULTIPLE SHORT V-V SENSED EVENTS OF < 220 MS ARE OBSERVED ON THE (B)(6) 2011, NOTED AS THE DATE OF DEATH. (8 EPISODES NST, 1 EPISODE VF). INTERFERENCE/NOISE - 29 V-SIC COUNTS ARE OBSERVED ON THE (B)(6) 2011, NOTED AS THE DATE OF DEATH.

    Additional Manufacturer Narrative · 1

    ASKU

    Additional Manufacturer Narrative · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INTERMITTENT MUSCLE STIMULATION AT HIGH LEFT VENTRICULAR OUTPUTS, REGARDLESS OF LV VECTOR. IT WAS LATER REPORTED THE PATIENT CODED APPROXIMATELY TEN MONTHS LATER AND WAS EXTERNALLY RESCUED. "CLINICIANS HAD ACKNOWLEDGED THAT THE DEVICE HAD APPROPRIATELY DETECTED THE EPISODE AS A MONITORED VT, ACCORDING TO CURRENT PROGRAMMED SETTINGS." PATIENT CODED A 2ND TIME AND CLINICIANS DECIDED TO LET HER GO. "STORED EPISODES SHOW THAT THE PATIENT WAS IN A MONITORED VT AT THE TIME THAT SHE CODED THE FIRST TIME AND AN AGONAL VF RHYTHM THE SECOND TIME." REPORTED THERE IS NO ASSOCIATED PRODUCT COMPLAINT OR ANY ALLEGATION OF ASSOCIATION BETWEEN PATIENT DEATH/INJURY AND PRODUCT PERFORMANCE. FOLLOW UP WITH CLINIC REPORTED THEY DID NOT HAVE INFORMATION AS TO CAUSE OF DEATH OR PACEMAKER DEPENDENCY. THEY DID REPORT PATIENT HAD MEDICAL HISTORY OF DILATED CARDIOMYOPATHY AND END STAGE RENAL FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED MUSCLE STIMULATION AT HIGH LEFT VENTRICULAR (LV) OUTPUTS, REGARDLESS OF LV VECTOR. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INTERMITTENT MUSCLE STIMULATION AT HIGH LEFT VENTRICULAR OUTPUTS, REGARDLESS OF LV VECTOR. IT WAS LATER REPORTED THE PATIENT CODED APPROXIMATELY TEN MONTHS LATER AND WAS EXTERNALLY RESCUED. "CLINICIANS HAD ACKNOWLEDGED THAT THE DEVICE HAD APPROPRIATELY DETECTED THE EPISODE AS A MONITORED VT, ACCORDING TO CURRENT PROGRAMMED SETTINGS." PATIENT CODED A 2ND TIME AND CLINICIANS DECIDED TO LET HER GO. "STORED EPISODES SHOW THAT THE PATIENT WAS IN A MONITORED VT AT THE TIME THAT SHE CODED THE FIRST TIME AND AN AGONAL VF RHYTHM THE SECOND TIME." REPORTED THERE IS NO ASSOCIATED PRODUCT COMPLAINT OR ANY ALLEGATION OF ASSOCIATION BETWEEN PATIENT DEATH/INJURY AND PRODUCT PERFORMANCE. CAUSE OF DEATH HAS BEEN REQUESTED AND 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 53 YR Death| H| L| O| R 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD| 5568 IMPLANTABLE PACING LEAD| 5568 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5568 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD| 5568 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB