BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 4160437 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11908
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, PRIOR TO THE PHYSICIAN SLITTING THE CATHETER, THE LEFT VENTRICULAR (LV) LEAD INSULATION WAS NOTED TO BE BREACHED BETWEEN THE PIN CONNECTOR AND THE SUTURE SLEEVE. THE LEAD WAS NOT USED AND A NEW LEAD WAS ATTEMPTED, HOWEVER THE SECOND LV LEAD HAD HIGH/UNSTABLE THRESHOLD. THE SECOND LEAD WAS NOT USED AND ANOTHER LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638559 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR SETROX-45 LEAD, SETROX-53 LEAD