BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSURITY MRI

    MDR report key: 9629084 · Received January 24, 2020

    Report

    Report Number
    2017865-2020-00952
    Event Type
    Injury
    Date Received
    January 24, 2020
    Date of Event
    January 8, 2020
    Report Date
    February 17, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    UDI-DI
    05414734509589
    PMA / PMN Number
    P140033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS /METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PER ANALYSIS UPDATE. ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    MANUFACTURER REPORT NUMBER: 2017865-2019-17554. MANUFACTURER REPORT NUMBER: 2017865-2020-00953. MANUFACTURER REPORT NUMBER: 2017865-2020-00954. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION. THE CAUSE OF THE INFECTION WAS NOT KNOWN. ALSO, THE RIGHT ATRIAL LEAD HAD ERODED THROUGH THE SKIN ON THE PATIENT¿S CHEST. THE PACEMAKER, RIGHT ATRIAL LEAD, RIGHT VENTRICULAR LEAD, AND PREVIOUSLY CAPPED RIGHT VENTRICULAR LEAD WERE EXPLANTED ON (B)(6) 2020. THE PATIENT WAS STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88797 ASSURITY MRI IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2272 A000070470 05414734509589

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention BI,TINED,IS-1, J ,ENDO LEAD| BIPOLAR POLYURETHANE LEAD| TENDRIL ST