BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 3990449 · Received August 7, 2014

    Report

    Report Number
    2649622-2014-08650
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 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

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

    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: 7120 LEAD IMPLANTED 2010-(B)(6), D314TRG ICD IMPLANTED 2012-(B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED, AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. THE ANALYST COMMENTED THAT ELECTRICAL CONTINUITY TEST RESULTS PASSED ELECTRICALLY AND VISUALLY USING DESTRUCTIVE TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD EARLY BATTERY DEPLETION DUE TO HIGH THRESHOLDS ON THE LEFT VENTRICULAR (LV) LEAD. LV CAPTURE WAS INTERMITTENT AT THE HIGHEST OUTPUT. THE DEVICE WAS EXPLANTED AND REPLACED. DURING THE DEVICE CHANGEOUT THE ORIGINAL INTENT WAS TO ATTEMPT TO REMOVE OR REPOSITION THE LV LEAD OR ADD AN ADDITIONAL LV LEAD. THE PATIENT¿S ANATOMY WOULD NOT ALLOW FOR ADDITIONAL LEADS TO BE PLACED BECAUSE THE SUBCLAVIAN WAS OCCLUDED. EXTRACTION WAS ABANDONED BECAUSE THE LEAD GOT HUNG UP IN THE SUPERIOR VENA CAVA (SVC). BECAUSE THE PATIENT WAS DEPENDENT, THE LV PORT WAS PLUGGED AND THE PATIENT WAS BROUGHT BACK AT A LATER TIME TO EXTRACT THE LEAD AND ADDED A NEW LV LEAD. DURING THE SUBSEQUENT PROCEDURE TO EXTRACT THE LEAD, THE LEAD BROKE IN HALF AND THE REMAINING PORTION WAS SNARED FROM BELOW USING FEMORAL ACCESS. THE LEAD WAS REMOVED AND REPLACED. DURING THE LV LEAD EXTRACTION, THE RIGHT ATRIAL (RA) LEAD DISLODGED AND WAS REPOSITIONED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463321 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419678

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| R 5076 LEAD