BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 2954598 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02345
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT, A STYLET WAS USED TO POSITION THE LEAD. WHEN THE LEAD WAS IN A GOOD POSITION, THE PHYSICIAN TRIED TO REMOVE THE STYLET. THE STYLET WOULD NOT REMOVE AND CAUSED THE LEAD TO BUCKLE. THE STYLET WAS CUT AND RETRACTED INTO THE LEAD RELIEVING THE BUCKLING. THE PHYSICIAN ELECTED TO LEAVE THE LEAD WITH CUT STYLET IN PLACE DUE TO GOOD THRESHOLDS AND PROLONGED CASE. THE STATUS OF THE LEAD IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59705 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 439688

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R