BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN PERFORMA S MRI SURESCAN

    MDR report key: 19044684 · Received April 4, 2024

    Report

    Report Number
    2649622-2024-09269
    Event Type
    Malfunction
    Date Received
    April 4, 2024
    Date of Event
    March 14, 2024
    Report Date
    May 7, 2024
    Manufacturer
    MPRI
    Product Code
    OJX
    UDI-DI
    00643169601864
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS INDICATED THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS OBSTRUCTED. VISUAL ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE ANALYST NOTED THE GUIDEWIRE WAS NOT RETURNED. VISUAL ANALYSIS SHOWED NO CONDUCTOR DISTORTION OR INSULATION BREACH WAS OBSERVED. THERE WAS ONLY BLOOD VISIBLE IN DISTAL END-20 CM OF THE LEAD. THE SAMPLE OF ATTAIN GWR 419478 WAS USED TO PERFORM INSERTION TEST, IT PASSED THE LEAD TIP NOSE BUT COULDN¿T GO ANY FURTHER AT 72 CM FROM THE IS-4 PIN, BY BACK LOADING. BY FRONT LOADING, THE GUIDEWIRE WAS PASSED THE IS-4 PIN BUT STOPPED AT THE SAME SPOT AS BACK LOADING AT 72 CM FROM THE IS-4 PIN. ONCE THE BLOOD WAS CLEARED BY USING THE WATER TO SOFTEN THE BLOOD, BY BACK LOADING AND FRONT LOADING, THE GUIDEWIRE WAS SUCCESSFULLY INSERTED INTO THE LEAD LUMEN. IT IS POSSIBLE THAT DRIED BLOOD COIL LUMEN MAY HAVE CAUSED OR CONTRIBUTED TO THE INSERTION DIFFICULTY EXPERIENCED DURING THE IMPLANT PROCEDURE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GUIDEWIRE WAS NOT ABLE TO GO DOWN THE LEFT VENTRICULAR (LV) LEAD. IT WAS SUSPECTED THAT THE INNER LUMEN OF THE LV LEAD WAS DAMAGED. THE LV LEAD WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57990 ATTAIN PERFORMA S MRI SURESCAN DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P OJX MPRI 459878 00643169601864

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male