BEUDAMED
    FDA Adverse Event Death Summary report: N

    IPERIA 7 HF-T DF4 PROMRI

    MDR report key: 6292652 · Received February 1, 2017

    Report

    Report Number
    1028232-2017-00157
    Event Type
    Death
    Date Received
    February 1, 2017
    Date of Event
    January 14, 2017
    Report Date
    January 16, 2017
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NIK
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AND ANALYZED. LEAD FRAGMENTS WERE STILL ATTACHED TO THE DEVICE. THE INITIAL DEVICE INTERROGATION REVEALED THAT THE SHIPMENT MODE WAS STILL ACTIVE AND THE TACHYTHERAPY WAS NOT ENABLED. THE BATTERY STATUS WAS MOL 1 AND A NUMBER OF SEVEN CHARGING CYCLES WAS DOCUMENTED. THE INSPECTION OF THE MEMORY CONTENT SHOWED A NORMAL DEVICE FUNCTION. IN A NEXT STEP, A SENSING TEST WAS PERFORMED AND THE DEVICE SENSED THE ATTACHED HEART SIGNALS FREE OF NOISE. THE ICD WAS SUBJECTED TO AN ELECTRICAL ANALYSIS. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE NORMAL AND IN AMPLITUDE AND FREQUENCY AS PROGRAMMED. A FIBRILLATION SIGNAL WAS APPLIED AND THE DEVICE DELIVERED A DEFIBRILLATION SHOCK AS SPECIFIED, DOCUMENTING A CORRECT SENSING AND SHOCK DELIVERY. IN PARTICULAR, THE SPECIFIED ENERGY LEVEL WAS REACHED. IN CONCLUSION, THE DEVICE PROVED TO BE FULLY FUNCTIONAL. THE ANALYSIS OF THE MEMORY CONTENT SHOWED A NORMAL DEVICE BEHAVIOR. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. BIOTRONIK MONITORS THE POST-MARKET PERFORMANCE OF ITS PRODUCTS CLOSELY IN ORDER TO IDENTIFY ANY TRENDS THAT MAY REVEAL OVER TIME A POTENTIAL MANUFACTURING OR DESIGN ISSUE. THE HISTORIC PERFORMANCE OF THE PRODUCT INVOLVED IN THE CURRENT CASE DOES NOT AT THIS POINT REVEAL ANY SUCH TREND.

    Additional Manufacturer Narrative · 1

    WE RECEIVED YOUR EVENT DESCRIPTION FOR THE ABOVE MENTIONED DEVICE AND WOULD LIKE TO THANK YOU FOR SUPPORTING OUR POST-MARKET SURVEILLANCE. AS OF TODAY, THE MEDICAL DEVICE IS NOT AVAILABLE FOR ANALYSIS, THEREFORE THE DEVICE ITSELF COULD NOT BE INVESTIGATED. THE INFORMATION YOU PROVIDED HAS BEEN ENTERED INTO OUR QUALITY SYSTEM AS A COMPLAINT. THESE TYPES OF COMPLAINTS ARE USED TO EVALUATE SYSTEMS AND DEVICE PERFORMANCE THROUGHOUT OUR ORGANIZATION AND HELP TO MAINTAIN AND IMPROVE THE PERFORMANCE OF OUR DEVICES. SHOULD ADDITIONAL RELEVANT INFORMATION OR THE DEVICE ITSELF BECOME AVAILABLE, THE INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    THE PATIENT EXPIRED WHILE ON THE OPERATING TABLE DURING IMPLANT. THE PATIENTS HEART RATE DROPPED AND THE PATIENT CODED. THE SYSTEM REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77484 IPERIA 7 HF-T DF4 PROMRI CRT-D NIK BIOTRONIK SE & CO. KG 393009

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death