BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 2454175 · Received February 15, 2012

    Report

    Report Number
    6000094-2012-00300
    Event Type
    Injury
    Date Received
    February 15, 2012
    Date of Event
    November 12, 2008
    Report Date
    April 1, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    Removal / Correction Number
    Z-0115-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE SAVE TO DISK REVIEW REVEALED NO ANOMALIES. IT WAS FURTHER REPORTED THE PATIENT WAS TREATED PHARMACOLOGICALLY AND THE DEVICE REMAINED IN USE. IN ADDITION PATIENT INFORMATION HAS BEEN OBTAINED AND ADDED. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. REFERENCED ARTICLE: "DEFIBRILLATION TESTING DURING IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR IMPLANTATION IN ITALIAN CURRENT PRACTICE: THE ASSESSMENT OF LONG-TERM INDUCTION CLINICAL VALUE (ALIVE) PROJECT." AMERICAN HEART JOURNAL. AUGUST 1 2011; 162(2):390-397.

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. REFERENCED ARTICLE: "DEFIBRILLATION TESTING DURING IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR IMPLANTATION IN ITALIAN CURRENT PRACTICE: THE ASSESSMENT OF LONG-TERM INDUCTION CLINICAL VALUE (ALIVE) PROJECT." AMERICAN HEART JOURNAL. AUGUST 1 2011;162(2):390-397.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS IMPLANTABLE CARDIAC DEFIBRILLATOR SYSTEM. THE PATIENT DEVELOPED A POCKET INFECTION. IT WAS FURTHER REPORTED THE PATIENT WAS TREATED PHARMACOLOGICALLY AND THE DEVICE WAS NOT EXPLANTED. THERE WAS NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS IMPLANTABLE CARDIAC DEFIBRILLATOR SYSTEM. THE PATIENT DEVELOPED A POCKET INFECTION. THERE WAS NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. D234DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R