BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA VR

    MDR report key: 5711216 · Received June 9, 2016

    Report

    Report Number
    3004209178-2016-11258
    Event Type
    Malfunction
    Date Received
    June 9, 2016
    Date of Event
    March 4, 2016
    Report Date
    September 7, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #ANALYSIS INFORMATION -- (B)(6) 2016, 19:42:32, CST PLI# 10, PRODUCT ID# D224VRC. THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. ANALYSIS INFORMATION -- (B)(6) 2016, 19:51:58, CST PLI# 30, PRODUCT ID# 694765. THE PROXIMAL PORTION OF THE LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. CONCOMITANT PRODUCT(S): PRODUCT ID: 694765, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT ID: CARELINK. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BATTERY VOLTAGE DID NOT DISPLAY ON THE REMOTE MONITOR TRANSMISSION. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD THRESHOLD WAS HIGH. THE CALLER WAS INFORMED OF WHAT THE BATTERY VOLTAGE HAD RECENTLY DISPLAYED. THE ICD AND RV LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BATTERY VOLTAGE DID NOT DISPLAY ON THE REMOTE MONITOR TRANSMISSION. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD THRESHOLD WAS HIGH. THE CALLER WAS INFORMED OF WHAT THE BATTERY VOLTAGE HAD RECENTLY DISPLAYED. THE ICD AND RV LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365443 SECURA VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR