BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 4831553 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05436
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 29, 2015
    Report Date
    April 29, 2015
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED STRETCHING AND APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

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

    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 ONE DAY POST IMPLANT IS WAS FOUND THAT THE LEFT VENTRICULAR (LV) LEAD HAD NO CAPTURE AT MAXIMUM OUTPUT AND CHEST X-RAY SHOWED THAT THE LEAD HAD PULLED BACK APPROXIMATELY 1-2 CENTIMETERS. THE LEAD WAS REMOVED AND ANOTHER LEAD WAS ATTEMPTED, HOWEVER IT MOVED AFTER PLACEMENT. THE LEAD WAS REMOVED 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
    374654 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Hospitalization| R DTBA1D4 ICD, 6947M62 LEAD