BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST AT

    MDR report key: 2454162 · Received February 15, 2012

    Report

    Report Number
    6000094-2012-00307
    Event Type
    Injury
    Date Received
    February 15, 2012
    Date of Event
    January 8, 2009
    Report Date
    April 1, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    Z-1172-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 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 INFORMATION HAS BEEN RECEIVED INCLUDING PATIENT DEMOGRAPHICS WHICH HAVE BEEN ADDED. 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. ANALYSIS FOUND NO ANOMALIES.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS SYSTEM. THE PATIENT HAD VENTRICULAR TACHYCARDIA. ALSO NOTED WAS THAT THE PATIENT HAD A DRUG CARDIOVERSION. THE STATUS OF THE SYSTEM IS UNKNOWN. FURTHER FOLLOW UP DID NOT YIELD ANY ADDITIONAL INFORMATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS SYSTEM. THE PATIENT HAD AN VENTRICULAR TACHYCARDIA. ALSO NOTED WAS THAT THE PATIENT HAD A DRUG/ELECTRICAL CARDIOVERSION. THE SYSTEM REMAINS IN USE. FURTHER FOLLOW UP DID NOT YIELD ANY ADDITIONAL INFORMATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTRUST AT IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. D154ATG

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R