BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY MRI SURESCAN

    MDR report key: 2203525 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-12124
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    April 7, 2011
    Report Date
    January 10, 2020
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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.

    Additional Manufacturer Narrative · 1

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

    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 EXHIBITED INCREASED THRESHOLDS. THE LEAD WAS REPOSITIONED AND IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED INCREASED THRESHOLDS. IT WAS LATER REPORTED THAT THE INCREASED LV LEAD THRESHOLD WAS A RESULT OF A DISLODGEMENT. THE LEAD WAS REPOSITIONED AND IS STILL IN USE. THE PATIENT WAS A PARTICIPANT IN THE (B)(4) STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    SUBSEQUENTLY, THE LV LEAD WAS CAPPED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT THE LV LEAD EXHIBITED CHRONICALLY HIGH, RISING, AND VARYING THRESHOLD. THE LV LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN ABILITY MRI SURESCAN DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7121 COMPETITOR IMPLANTABLE TACHY LEAD| 7121 COMPETITOR IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD