BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY STRAIGHT

    MDR report key: 3863152 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06548
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #(B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND 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: 407645 LEAD, IMPLANTED::(B)(6) 2014, A DTBA1D4 BIV ICD, IMPLANTED: (B)(6) 2014. (B)(4).

    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 LEFT VENTRICULAR (LV) LEAD HAD NO CAPTURE IN ALL CONFIGURATIONS. IT WAS ALSO REPORTED THAT THE LV LEAD HAD PULLED BACK INTO THE RIGHT VENTRICLE. THE LV LEAD WAS EXPLANTED 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
    340639 ATTAIN ABILITY STRAIGHT DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 439678

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R 6947M62 LEAD