BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIA MRI CRT-D SURESCAN

    MDR report key: 9603359 · Received January 17, 2020

    Report

    Report Number
    3004209178-2020-01331
    Event Type
    Injury
    Date Received
    January 17, 2020
    Date of Event
    December 31, 2019
    Report Date
    January 17, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NIK
    UDI-DI
    00643169720657
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 511211 GREATBATCH, LEAD; 511212 GREATBATCH LEAD, IMPLANTED (B)(6) 2019. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY SHOWED THE BATTERY IS APPROACHING THE INDICATOR SIGNIFYING THE TIME FOR DEVICE REPLACEMENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED 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
    63484 CLARIA MRI CRT-D SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO. DTMA1D4 00643169720657

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R