BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM

    MDR report key: 1990147 · Received February 15, 2011

    Report

    Report Number
    2647346-2011-00150
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 3, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P900061/S47
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. BATTERY VOLTAGE=2.36 VOLT ON (B)(4) 2010 15:53:38. SAVE TO DISK FROM POR (POWER ON RESET) TEXT FILE, SHOWS DEVICE IN EOL (END OF LIFE), DEVICE ERI (ELECTIVE REPLACEMENT INDICATOR) <=2.55 V, DEVICE END OF LIFE EOL<=2.40 V. 1 -POR FOR VDD POR VREG MONITOR AND WATCHDOG ON (B)(4) 2010 09:25:33. 1 - PATIENT ALERT FOR POR ON (B)(6) 2010 09:25:33.

    Additional Manufacturer Narrative · 1

    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, AN ABDOMINALLY-IMPLANTED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), DELIVERED INAPPROPRIATE SHOCKS DURING AN OPEN-HEART SURGERY. THE DEVICE HAD BEEN PREVIOUSLY REPLACED BY A PECTORALLY-PLACED ICD, AND INACTIVATED THROUGH PROGRAMMING, BUT WAS LEFT IMPLANTED AND CONNECTED TO AN EPICARDIAL PATCH ELECTRODE. DURING THE SURGERY THE ABDOMINAL DEVICE, WHOSE PRESENCE WAS NOT INITIALLY KNOWN TO THE SURGEON, EXPERIENCED A POWER-ON-RESET AND DELIVERED SIX SHOCKS DUE TO OVERSENSING DURING ELECTROCAUTERY. THE SURGEON CUT THE CONDUCTOR BETWEEN THE ICD AND THE PATCH ELECTRODE. THE DEVICE REMAINS IMPLANTED AND NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE, AN ABDOMINALLY-IMPLANTED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), DELIVERED INAPPROPRIATE SHOCKS DURING AN OPEN-HEART SURGERY. THE DEVICE HAD BEEN PREVIOUSLY REPLACED BY A PECTORALLY-PLACED ICD, AND INACTIVATED THROUGH PROGRAMMING, BUT WAS LEFT IMPLANTED AND CONNECTED TO AN EPICARDIAL PATCH ELECTRODE. DURING THE SURGERY THE ABDOMINAL DEVICE, WHOSE PRESENCE WAS NOT INITIALLY KNOWN TO THE SURGEON, EXPERIENCED A POWER-ON-RESET AND DELIVERED INAPPROPRIATE THERAPY DUE TO NOISE DURING ELECTROCAUTERY. THE SURGEON CUT THE CONDUCTOR BETWEEN THE ICD AND THE PATCH ELECTRODE. THE DEVICE WAS NOTED TO BE AT EOL (END OF LIFE). THE DEVICE REMAINS IMPLANTED AND NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7227E ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| R 6947 IMPLANTABLE TACHY LEAD| 6947 IMPLANTABLE TACHY LEAD| D274VRC IMPLANTABLE PACEMAKER/CARDIO/DEFIB| D274VRC IMPLANTABLE PACEMAKER/CARDIO/DEFIB