BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN SD

    MDR report key: 3861790 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01750
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 26, 2014
    Report Date
    April 29, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME TO A DEVICE MARKETED IN THE U.S. CONCOMITANT PRODUCT: 4592-53 LEAD, IMPLANTED (B)(6) 2001; 693675 LEAD, IMPLANTED (B)(6) 1995. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL PRODUCT WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND WAS ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/ SHORT INTERVAL COUNTS (SIC). SOME IMPEDANCES NOT MEASURED; LV TIP TO RING AND TIP TO COIL ARE UNDEFINED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TRANSMISSION OBSERVED THE RIGHT VENTRICULAR (RV) LEAD HAD OVERSENSING. THE RV LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD MEASURED HIGH IMPEDANCE. THE LV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341820 ATTAIN SD PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC. 418985

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR D224TRK ICD