BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3050085 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03701
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    January 2, 2013
    Report Date
    November 17, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENT INFORMATION WAS RECEIVED FROM THIS PATIENT STATING THAT HE HAD BEEN IN A CAR ACCIDENT RELATED TO A SHOCK DELIVERED BY THE DEVICE ONE MONTH AGO. HE HIT A STEEL POLE AND TOTALED OUT HIS CAR. HE STATED THAT THE DEVICE HESITATED AFTER GIVING HIM THE FIRST SHOCK AND HE SUSPECTS THE DEVICE BATTERY IS TOO WEAK TO GIVE HIM SHOCK AFTER SHOCK IN QUICK SUCCESSION. THE PATIENT AND HIS WIFE BELIEVE THE DEVICE MIGHT NOT BE CAPABLE OF SAVING HIS LIFE. THE DEVICE WAS INTERROGATED BY HIS PHYSICIAN WHO SAID THE DEVICE IS FUNCTIONING APPROPRIATELY. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THAT THE DEVICE IS PROGRAMMED BY THE PHYSICIAN TO RECOGNIZE AND TREAT THE RHYTHMS THAT IT DETERMINES NEED TO BE TREATED. IN AN ONGOING EPISODE THE DEVICE EVALUATES THE RESULTING RHYTHM AFTER THE FIRST SHOCK WHILE IT IS CHARGING UP TO MAXIMUM ENERGY. THIS MAY NOT BE REFLECTIVE OF A WEAK BATTERY. DETAILS OF THE EPISODE AND INTERPRETATION OF WHAT THE DEVICE SAW AND DID SHOULD BE REVIEWED WITH HIS PHYSICIAN AS WELL AS BATTERY STATUS AND CHARGE TIME. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUBSEQUENTLY EXPLANTED FOR AN UNSPECIFIED REASON AND WAS RETURNED FOR TESTING OVER FOUR YEARS AFTER THE INITIAL OBSERVATIONS WERE REPORTED. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A VISUAL INSPECTION OF THE DEVICE NOTED NO ANOMALIES. REVIEW OF THE STORED MEMORY CONFIRMED A SHORTED LEAD INDICATOR WAS RECORDED BY THE DEVICE ON (B)(4) 2017. THERAPY AVAILABILITY TESTING COULD NOT BE COMPLETED AS A RESULT OF THE INDUCED DAMAGE TO THE DEVICE. BASED ON INSPECTION AND ANALYSIS OF THIS DEVICE, EVIDENCE INDICATES THE DEVICE WAS DAMAGED AFTER DELIVERING A SHOCK THROUGH A SHORTED DEFIBRILLATION LEAD. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE RED ALERT WAS GENERATED FROM THIS LEAD DUE TO A SHOCK IMPEDANCE OF 0 OHMS. THE PATIENT WAS BROUGHT INTO THE CLINIC AND COMMANDED MEASUREMENTS PRODUCED CONSISTENT IMPEDANCES OF 50-51 OHMS, INCLUDING MEASUREMENTS DURING POCKET MANIPULATIONS. THE CALLER REVIEWED THE LEAD DATA VIA LATITUDE WHICH SHOWED STEADY MEASUREMENTS IN THE 45- 55 OHM RANGE. ADDITIONALLY, THERE IS NO NOISE ON THE PRESENTING DATA OR ON THE MOST RECENT STORED EVENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE CLINICAL OBSERVATIONS WITH THE CALLER AND RECOMMENDED ADDITIONAL TESTING. THE CALLER CONFIRMED THAT NON-INVASIVE PROGRAMMED STIMULATION (NIPS) WILL NOT BE DONE AT THIS TIME. THE PHYSICIAN WILL CONTINUE TO MONITOR THIS LEAD. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152200 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L N118| H175| 4470| 0185| 4518