BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 2988476 · Received March 4, 2013

    Report

    Report Number
    9614453-2013-00547
    Event Type
    Death
    Date Received
    March 4, 2013
    Date of Event
    February 5, 2013
    Report Date
    May 2, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE MET 34 PERCENT OF THE EXPECTED LONGEVITY. PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED CHARGE TIME LONGER THAN EXPECTED AND ALERT DUE TO LOW BATTERY VOLTAGE.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4). THE ACTUAL DEVICE WAS RECEIVED AND PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED INCONCLUSIVE DEVICE ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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. CONCOMITANT PRODUCTS: 6947 IMPLANTABLE DEFIBRILLATION LEAD (B)(6) 2008; 4194 IMPLANTABLE PACING LEAD (B)(6) 2008. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR PREMATURELY. THE DEVICE WAS RECOMMENDED FOR REPLACEMENT. THE PATIENT WAS ADMITTED TO A FACILITY AND WAS REQUIRED TO AWAIT TRANSFER TO ANOTHER FACILITY FOR AN OPEN BED TO BECOME VACANT. ONCE TRANSFERRED TO THE NEW FACILITY THE DEVICE REPLACEMENT WAS SCHEDULED FOR THE FOLLOWING DAY. DURING THE NIGHT THE VENTRICULAR ARRHYTHMIA (VENTRICULAR FIBRILLATION) OCCURRED, EXTERNAL DEFIBRILLATION WAS ATTEMPTED BUT WAS UNSUCCESSFUL AT CONVERTING THE RHYTHM AND THE PATIENT EXPIRED. THE DATA STORED IN THE DEVICE INDICATED THAT THE PATIENT EXPERIENCED MULTIPLE ARRHYTHMIA EPISODES INCLUDING FOUR EPISODES OF VENTRICULAR FIBRILLATION ON THE PREVIOUS DAY WHICH EXTERNAL DEFIBRILLATION WAS SUCCESSFUL TO CONVERT TO SINUS RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90824 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND D354TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Death 5076 IMPLANTABLE PACING LEAD