BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN PERFORMA S MRI SURESCAN

    MDR report key: 10689707 · Received October 16, 2020

    Report

    Report Number
    2649622-2020-19881
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Date of Event
    September 29, 2020
    Report Date
    October 16, 2020
    Manufacturer
    MPRI
    Product Code
    OJX
    UDI-DI
    00643169601871
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY/UF/IMPORTER RPT NUM: (B)(6). USER FACILITY NAME/ADDRESS: (B)(6). DATE USER FACILITY BECAME AWARE OF EVENT: 09/29/2020. TYPE OF REPORT: INITIAL. DATE OF THIS REPORT: 09/30/2020. APPROXIMATE AGE OF DEVICE: UNK . EVENT PROBLEM CODES: (B)(4). REPORT SENT TO FDA: NO. REPORT SENT TO MANUFACTURER: 09/30/2020. MANUFACTURER NAME AND ADDRESS MFR. NAME: MEDTRONIC, PLC ADDL: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, A COMPETITOR GUIDE WIRE BROKE INSIDE THE LEFT VENTRICULAR (LV) LEAD. THE WIRE WAS REMOVED FROM THE LEAD. THE LV LEAD WAS REMOVED, AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156449 ATTAIN PERFORMA S MRI SURESCAN DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 459888 00643169601871

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR