BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPERIA 7 DR-T DF-1 PROMRI

    MDR report key: 12278063 · Received August 4, 2021

    Report

    Report Number
    1028232-2021-04407
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    August 2, 2021
    Report Date
    August 2, 2021
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    UDI-DI
    04035479128777
    PMA / PMN Number
    P050023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EXPLANTED (B)(6) 2021. 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. PLEASE NOTE THIS ICD IS AFFECTED BY A FIELD SAFETY CORRECTIVE ACTION, BIO-LQC, INITIATED IN MARCH 2021.

    Additional Manufacturer Narrative · 0

    DEVICE EXPLANTED (B)(6) 2021. UPON RECEIPT, THE DEVICE WAS INTERROGATED. THE INTERROGATION COULD BE PROPERLY PERFORMED AND REVEALED THE ERI BATTERY STATUS, CONFIRMING THE CLINICAL OBSERVATION. NEXT, THE ICD WAS SUBJECTED TO AN ANALYSIS OF THE ELECTRICAL PARAMETERS. THE CURRENT CONSUMPTION OF THE ICD WAS CHECKED AND FOUND TO BE NORMAL AND AS EXPECTED. ANALYSIS OF THE BATTERY CONDITION, HOWEVER, SHOWED AN INCONSISTENCY OF CHARGE TAKEN FROM THE BATTERY AND THE BATTERY VOLTAGE. A PREMATURE BATTERY DEPLETION COULD BE CONFIRMED DURING ANALYSIS. PLEASE NOTE, THIS ICD IS AFFECTED BY THE FIELD SAFETY CORRECTIVE ACTION, BIO-LQC, INITIATED IN (B)(6) 2021.

    Description of Event or Problem · 1

    DEVICE REMAINS IMPLANTED. PER HOME MONITORING, PREMATURE ERI HAS OCCURRED. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174323 IPERIA 7 DR-T DF-1 PROMRI ICD MRM BIOTRONIK SE & CO. KG 392409 04035479128777

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male