BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2060044 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05808
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 14, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-0609-10 TO Z-0610-10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS FURTHER EVALUATED FOR THIS ISSUE AND UNDERWENT A NON-INVASIVE PROGRAMMED STIMULATION IN WHICH 11 JOULE SHOCK WAS DELIEVERED WITH 34 OHMS MEASURED. THE PHYSICIAN HAS ELECTED TO CONTINUE TO MONITOR THIS ISSUE.

    Additional Manufacturer Narrative · 1

    IT WAS LATER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD MEASURED GREATER THAN 2000 OHMS, A LOSS OF CAPTURE AND LOW AMPLITUDES. THERE WAS FURTHER INQUIRY OF VENTRICULAR EVENTS. THE FIELD REPRESENTATIVE REPORTED THAT THE VERY QUICK SHARP DEFLECTIONS DID NOT APPEAR TO BE NOISE BUT WAS TOO FAST TO BE PHYSIOLOGIC. THE RV LEAD IMPEDANCES HAD BEEN STEADY IN THE 640-680 OHMS RANGE AND THE SHOCK IMPEDANCES CONTINUE TO BE HIGH AND OUT OF RANGE FOR SOME TIME OF WHICH THE PHYSICIAN WAS AWARE. THIS RECENT NOISE DID NOT RESULT IN ANY UNNECESSARY THERAPY AND DID NOT APPEAR RESULT IN PACING INHIBITION IN THIS DEPENDENT PATIENT. TECHNICAL SERVICES REVIEWED AND DISCUSSED POSSIBLE NOISE AND FURTHER INTERVENTION WARRANTED FOR SYSTEM INTEGRITY. THE PHYSICIAN ELECTED TO FURTHER INVESTIGATE. UPON OPENING THE POCKET, THE PHYSICIAN ALLEGED A LOOSE HEADER WAS NOTED. THE DEVICE WAS REPLACED WITH A NON-BOSTON SCIENTIFIC DEVICE. THE PHYSICIAN SUSPECTED FRACTURED LEADS, HOWEVER, THE CHRONIC LEADS WERE ATTACHED TO THIS NEW DEVICE WITH SUCCESSFUL DEFIBRILLATION TESTING AND NO LEAD ISSUES WERE NOTED. THE FIELD REPRESENTATIVE REPORTED THAT THE HEADER APPEARED TO BE INTACT. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED THE CLINICAL OBSERVATION OF A WEAKENED HEADER BOND WITH MEDICAL ADHESIVE SEPARATED FROM THE HEADER ON THREE SIDES. AN X-RAY EXAMINATION WAS PERFORMED. THE RA AND SHOCK HEADER WIRE WERE FOUND TO BE FRACTURED. IMPROVEMENTS HAVE BEEN MADE TO THE MANUFACTURING PROCESS IN ORDER TO STRENGTHEN THE BOND BETWEEN THE HEADER AND THE DEVICE CASE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A SIMILAR MEASUREMENT WAS AGAIN OBSERVED AND THE PHYSICIAN HAS ELECTED TO CONTINUE TO MONITOR.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS SCHEDULED FOR A REVISION IN THE NEAR FUTURE. ALL AVAILABLE INFORMATION INDICATES THAT THESE PRODUCTS REMAIN IN SERVICE. 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 THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED GREATER THAN 125 OHMS ON THIS RIGHT VENTRICULAR LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. TROUBLESHOOTING WAS DISCUSSED WITH TECHNICAL SERVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R 4542| N119| 1831| (B)(4)| 0134| T125