BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN BIPOLAR OVER THE WIRE LEAD

    MDR report key: 8824175 · Received July 24, 2019

    Report

    Report Number
    2649622-2019-13001
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Date of Event
    July 1, 2019
    Report Date
    August 12, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO VILLALBA
    Product Code
    LWP
    UDI-DI
    00885074113371
    PMA / PMN Number
    P010015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 6935M62 LEAD IMPLANTED:(B)(6) 2019, DTMA1D4 ICD IMPLANTED: (B)(6) 2019. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOW IMPEDANCE ALERT ON THE LEFT VENTRICULAR (LV) LEAD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616126 ATTAIN BIPOLAR OVER THE WIRE LEAD IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP MEDTRONIC PUERTO RICO VILLALBA 419488 00885074113371

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male 6996SQ58 LEAD