BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA VR

    MDR report key: 3863082 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01310
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    August 17, 2013
    Report Date
    August 20, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE U.S., HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT OCCURRED OUTSIDE THE US AND IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DURING EXERCISE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS REPROGRAMMED AND REMAINS IN USE. THE PATIENT IS ENROLLED IN THE OPTILINK HF CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339423 SECURA VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D234VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Life Threatening| R 694765 IMPLANTABLETACHY LEAD