BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERA MRI XT DR SURESCAN

    MDR report key: 8741104 · Received June 27, 2019

    Report

    Report Number
    3004209178-2019-12544
    Event Type
    Injury
    Date Received
    June 27, 2019
    Date of Event
    June 7, 2019
    Report Date
    July 26, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LWS
    UDI-DI
    00643169929197
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. RETURNED PRODUCT ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE DEVICE WAS RETURNED AND SCREENING ANALYSIS WAS PERFORMED, BUT NO ISSUE WAS IDENTIFIED REQUIRING FULL ANALYSIS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 6945-65 LEAD, IMPLANTED: (B)(6) 1998; M7700-31 MECHANICAL VALVE, IMPLANTED: (B)(6) 1994. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. CULTURES WERE TAKEN, AND THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE CULTURES TESTED POSITIVE FOR STAPH CAPITUS. A NEW ICD SYSTEM WAS IMPLANTED AT A LATER DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532398 EVERA MRI XT DR SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO. DDMB1D1 00643169929197

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R 5076-45 LEAD