BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 4162959 · Received October 10, 2014

    Report

    Report Number
    9614453-2014-02493
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: A 429688 LEAD, IMPLANTED (B)(6) 2011. A 5524M-53 LEAD, IMPLANTED: (B)(6) 1999. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE DID NOT DETECT ANY PERFORMANCE ISSUES, BUT THE CALCULATED LONGEVITY RESULT OF 82% OF EXPECTED WAS LESS THAN THE PREDICTED VALUE BASED ON THE AVAILABLE PROGRAMMED PARAMETERS. IN THE ABSENCE OF THE COMPLETE PROGRAMMING HISTORY, IT IS NOT POSSIBLE TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO POSSIBLE PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640704 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND D314TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R 693565 LEAD