BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 2864937 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17588
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    August 8, 2012
    Report Date
    December 19, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. HIGH IMPEDANCE WAS NOTED. THE MAXIMUM SUPERIOR VENA CAVA LEAD IMPEDANCE MEASUREMENT ON (B)(6) 2012 WAS 1664 OHMS. AN OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ALERT WAS REGISTERED ON (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. 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 SUPERIOR VENA CAVA (SVC) PORTION OF THE RIGHT VENTRICULAR (RV) LEAD EXPERIENCED A SUDDEN INCREASE IN IMPEDANCE AND TRIGGERED A PATIENT ALERT FOR HIGH IMPEDANCE. THE PARAMETERS ON THE LEAD WERE REPROGRAMMED AND THE LEAD REMAINS 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
    1 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention D164AWG IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD)