BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 2965168 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01824
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    December 26, 2012
    Report Date
    February 21, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS 6949 IMPLANTABLE TACHY LEAD - (B)(6) 2007, 5076 IMPLANTABLE PACING LEAD - (B)(6) 2007, 4193 IMPLANTABLE PACING LEAD - (B)(6) 2007. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, IT WAS NOT POSSIBLE TO OBTAIN GOOD SENSING OR PACING THRESHOLDS WHEN REPLACING THE LEFT VENTRICULAR (LV) LEAD. THE LEAD WAS REMOVED, AND ANOTHER LEAD WAS ATTEMPTED, WITH THE SAME RESULTS. THE SECOND LEAD WAS ALSO NOT USED, AND THE PREVIOUSLY IMPLANTED LEAD WAS RECONNECTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, IT WAS NOT POSSIBLE TO OBTAIN GOOD SENSING OR PACING THRESHOLDS WHEN REPLACING THE LEFT VENTRICULAR (LV) LEAD. THE LEAD WAS REMOVED, AND ANOTHER LEAD WAS ATTEMPTED, WITH THE SAME RESULTS. THE SECOND LEAD WAS ALSO NOT USED, AND THE PREVIOUSLY IMPLANTED LEAD WAS RECONNECTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68131 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR D224TRK IMPLANTABLE DEFIBRILLATOR