BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 6160579 · Received December 9, 2016

    Report

    Report Number
    2649622-2016-14112
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    September 6, 2016
    Report Date
    September 6, 2016
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. THE PROXIMAL AND DISTAL CONDUCTORS OF THE LEAD DEVELOPED FRACTURES DUE TO FLEXING WHILE IN VIVO. THE LV2 (LOW VOLTAGE 2)/PROXIMAL AND DISTAL CONDUCTORS WERE OBSTRUCTED DUE TO STYLET/GUIDEWIRE FRAGMENTS STUCK IN THE LUMEN.

    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 THE LEFT VENTRICULAR (LV) LEAD WAS EXHIBITING NON-CAPTURE AND THAT PACING IMPEDANCE HAD RISEN. LEAD FRACTURE WAS SUSPECTED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812103 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419678

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R D314TRG CRT-D, 7122 LEAD, 5076 LEAD