BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1954205 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24701
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 16, 2010
    Report Date
    January 7, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW, THERE ARE NO REPORTABLE ISSUES ASSOCIATED WITH EITHER THIS RV LEAD OR THE ASSOCIATED ICD. THE DECREASE IN RV PACE IMPEDANCE HAD BEEN THE RESULT OF PATIENT CONDITION. FINAL ANALYSIS OF THE RETURNED LEAD DETERMINED NO FINDINGS OF A PRODUCT PERFORMANCE ISSUE. THE SEPARATELY REPORTED DEVICE WAS DETERMINED TO HAVE PERFORMED WITHIN NORMAL LIMITS IN ANALYSIS ALSO. THERE WAS NO EVIDENCE OF ADVERSE EFFECT FROM RADIATION ON THE MEDICAL DEVICES. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    MOST RECENTLY, THIS MEDICAL DEVICE HAS BEEN RETURNED TO THE BOSTON SCIENTIFIC POST MARKET QUALITY ASSURANCE LABORATORY BUT ANALYSIS REMAINS INCONCLUSIVE TO DATE. AS NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED. THE INVESTIGATION REMAINS OPEN AT THIS TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE ASSOCIATED TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD DID EXHIBIT A RISE IN IMPEDANCE, ALTHOUGH STILL WITHIN NORMAL LIMITS. THE PHYSICIAN DETERMINED THAT THE RV LEAD ISSUE WAS TO BE ADDRESSED IN A LEAD REVISION PROCEDURE. THE BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT CONCURRED WITH THE PHYSICIAN'S DECISION FOR EARLY SURGICAL INTERVENTION TO REPLACE THE RV LEAD AS WELL AS THE ASSOCIATED DEVICE. THE PATIENT HAD RECENTLY UNDERGONE RADIATION THERAPY. THIS OR THE IMPACT OF CHANGE IN IMPEDANCE MAY HAVE CAUSED OR CONTRIBUTED TO THE ASSOCIATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR REACHING ELECTIVE REPLACEMENT INDICATOR (ERI) EARLIER THAN EXPECTED. THE BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT CONCURRED WITH THE PHYSICIAN'S DETERMINATION TO REMOVE THE LEAD AND THIS DEVICE FROM SERVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THESE CLINICAL OBSERVATIONS, BEYOND THE UPCOMING EARLY SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other 4088| S603| 4087| 1290| 4137