BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS MRI SURESCAN

    MDR report key: 3992021 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-10084
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    April 9, 2014
    Report Date
    August 26, 2020
    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. PRODUCT EVENT SUMMARY : THE FULL LEAD WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND. THE DISTAL CONDUCTOR WAS DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS. VISUAL ANALYSIS NOTED THE LEAD HAD APPARENT EXPLANT DAMAGE AND WAS STRETCHED. CONCOMITANT PRODUCTS : 6935-65 LEAD IMPLANTED (B)(6) 2012; D314TRG ICD IMPLANTED (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE INDICATED ELECTIVE REPLACEMENT (ERI) EARLY. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR LEAD DISLODGED, AND IT WAS NOT SENSING AND HAD HIGH THRESHOLD. THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED. THE PATIENT WAS A PARTICIPANT IN THE SYSTEM (B)(6). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468970 ATTAIN ABILITY PLUS MRI SURESCAN DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| R 4076-52 LEAD| 4076-52 LEAD