BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA CRT-D

    MDR report key: 3991519 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01697
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 2, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    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 94% 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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #GEO EVENT DESCRIPTION: IT WAS REPORTED THAT THIS PROTECTA CARDIOVERTER RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) TRIPPED RECOMMENDED REPLACEMENT TIME (RRT) DUE TO POSSIBLE PREMATURE BATTERY DEPLETION. PRELIMINARY GEO ASSESSMENT: NO HISTORICAL DATA PROVIDED - LV OUTPUT SETTINGS WERE 5.5V, AND RV AT 3V - ACCORDING TO PPR THE MINIMUM EXPECTED LONGEVITY IS 3.2 YEARS - HIGH LV OUTOUT SETTINGS MAY HAVE CONTRIBUTED TO REDUCED SERVICE LIFE - WILL REQUEST TO CREATE STD WHEN DEVICE IS RECEIVED AT EOC - DEVICE NOT ENROLLED ON CARELINK PRELIMINARY GEO CONCLUSION: SUSPECT HIGH OUTPUT SETTINGS CONTRIBUTED TO RAPID BATTERY DEPLETION ((B)(4), (B)(6) 2014); ANALYSIS OF STD - LONGEVITY CALCULATION INDICATES THE DEVICE MET ITS EXPECTED LONGEVITY ((B)(4), (B)(6) 2014). (B)(4).

    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 DEVICE HAD AN UNEXPECTED LONGEVITY OF LESS THAN TWO YEARS AFTER IMPLANT. 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
    470425 PROTECTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND D364TRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Hospitalization| R