BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 4970668 · Received August 5, 2015

    Report

    Report Number
    2649622-2015-08417
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    June 9, 2015
    Report Date
    June 10, 2015
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS FOUND HIGH THRESHOLDS ON THE LEFT VENTRICULAR LEAD. THE LEFT VENTRICULAR CAPTURE MANAGEMENT TREND DATA SHOW THRESHOLD MEASUREMENT VARIABLE SINCE INITIAL WEEK OF IMPLANT. THRESHOLD MEASUREMENTS VARIED FROM 0.375 VOLTS (V) UP TO GREATER THAN 6 V. LAST SUCCESSFUL THRESHOLD MEASUREMENT ON (B)(6) 2015 WAS 5 V AT 0.4 MS. CONCOMITANT MEDICAL PRODUCTS: 694765 LEAD, IMPLANTED: (B)(6) 2008. 5076-52 LEAD, IMPLANTED: (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD HIGH IMPEDANCE, NOISE NOTED ON THE ELECTROGRAMS, AND A FRACTURE WAS CONFIRMED. THE LEAD WAS CAPPED AND REPLACED. THE LEFT VENTRICULAR LEAD WAS ALSO NOTED TO BE DISLODGED. THE LEAD WAS EXPLANTED AND NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513975 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419678

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| R DTBB1D1 ICD