BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY STRAIGHT

    MDR report key: 4161814 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11312
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    June 6, 2014
    Report Date
    August 13, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 PRODUCT : 6935-65 LEAD, IMPLANTED (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A DEVICE UPGRADE, THE PATIENT EXPERIENCED THE "CHEST MOVING WITH HEART BEATS" AND IT FELT LIKE HICCUPS. IT WAS LATER REPORTED THAT THE LEAD WAS DISLODGED AND CAUSING STIMULATION. THE LEAD WAS REPROGRAMMED. THEN A SUDDEN THRESHOLD RISE ON THE LEFT VENTRICULAR LEAD OCCURRED AND THERE WAS NO CAPTURE, EVEN AT MAXIMUM OUTPUT AND WHEN THE LEAD WAS PROGRAMMED TO VARIOUS PACING CONFIGURATIONS. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS A PARTICIPANT IN THE PRODUCT SURVEILLANCE REGISTRY STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639685 ATTAIN ABILITY STRAIGHT DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 439688

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R DTBA1D1 ICD, 5076-52 LEAD