BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN BIPOLAR OVER THE WIRE LEAD

    MDR report key: 23758177 · Received December 9, 2025

    Report

    Report Number
    2649622-2025-34280
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    November 22, 2025
    Report Date
    December 9, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO VILLALBA
    Product Code
    LWP
    UDI-DI
    00885074113364
    PMA / PMN Number
    P010015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: 0185 LEAD, IMPLANTED (B)(6) 2006. 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 BI-VENTRICULAR (BI-V) CAPTURE COULD NOT BE CONFIRMED ON THE CURRENT ELECTROGRAM AND THE PATIENT WAS HAVING PAUSES. THE LEFT VENTRICULAR (LV) LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2796619 ATTAIN BIPOLAR OVER THE WIRE LEAD IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP MEDTRONIC PUERTO RICO VILLALBA 419478 00885074113364

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male DTPA2D1 CRT-D