BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPICARDIAL PATCH

    MDR report key: 1842689 · Received September 23, 2010

    Report

    Report Number
    2182208-2010-00633
    Event Type
    Injury
    Date Received
    September 23, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P900061/S2
    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. INFORMATION SUBSEQUENTLY RECEIVED ON 9/22/2010 REVEALED THE PATIENT HAD DIED. OF NOTE, THE REPORTABLE MALFUNCTION IS NORMALLY SUBMITTED VIA A BIMONTHLY MEDWATCH REPORT SUBMISSION THAT WOULD HAVE BEEN DUE ON 10/10/2010. HOWEVER, AS THERE IS NOW INFORMATION THAT REASONABLY SUGGESTS THAT THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, THIS NOW REQUIRES SUBMISSION AS A 30-DAY REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER 18 EPISODES OF VENTRICULAR TACHYCARDIA AND HEARTRATE IN THE 30S. DEVICE REPORTED TO HAVE NO CAPTURE AND UPON INTERROGATION, PROGRAMMED TO A LOW RATE OF 40. THRESHOLD NOTED TO BE 8V AT 1.1MS AND R-WAVE 12.2MV. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED 6 DAYS LATER. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. FOLLOW UP WITH CLINIC REVEALED CAUSE OF DEATH TO BE SUSPECTED MULTISYSTEM FAILURE. PATIENT WAS NOT HISTORICALLY PACEMAKER DEPENDENT AND LAST SEEN BY CLINIC ON (B)(6) 2010 WITH REPORT OF NO VENTRICULAR EVENTS OR THERAPIES AND UNDERLYING ATRIAL FIBRILLATION IN THE 60S. ON (B)(6) 2007, VENTRICULAR CAPTURE COULD NOT BE OBTAINED EVEN AT HIGHEST OUTPUTS, BUT HCP FELT PATIENT "TOO HIGH RISK FOR COMPLICATIONS WITH REPEAT OPERATION." ALSO REPORTED DEVICE HAD SHOCKED PATIENT APPROPRIATELY AND CONVERTED HIM IN THE PAST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER 18 EPISODES OF VENTRICULAR TACHYCARDIA AND HEARTRATE IN THE 30S. DEVICE REPORTED TO HAVE NO CAPTURE AND UPON INTERROGATION, PROGRAMMED TO A LOW RATE OF 40. THRESHOLD NOTED TO BE 8V AT 1.1MS AND R-WAVE 12.2MV. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED 6 DAYS LATER. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPICARDIAL PATCH IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6721M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death