BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY STRAIGHT

    MDR report key: 3153721 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06184
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD, (B)(6) 2013; 6935M IMPLANTABLE TACHY LEAD, (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

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

    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 DAY AFTER IMPLANT, THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION. THE LEFT VENTRICULAR (LV) LEAD HAD DISLODGED INTO CORONARY SINUS AND HAD NO CAPTURE. DUE TO THE PATIENT'S POOR ANATOMY OPTIONS FOR PLACEMENT, THE LEAD WAS EXPLANTED AND NOT REPLACED. AN EPICARDIAL LEAD MAY BE PLACED AT A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257502 ATTAIN ABILITY STRAIGHT DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 439688

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R D314TRM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC