BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 4162661 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12667
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 PRODUCTS: 6947-65 LEAD IMPLANTED: (B)(6) 2011; D314TRG ICD IMPLANTED: (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS REPLACED DUE TO EARLY BATTERY DEPLETION. THE BATTERY LONGEVITY WAS LESS THAN EXPECTED. THE DEVICE WAS REMOVED AND A NEW DEVICE WAS IMPLANTED. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND THE LEFT VENTRICULAR (LV) LEAD HAD HIGH PACING THRESHOLDS. THE PHYSICIAN ELECTED TO LEAVE THE LEADS IN USE. A FEW DAYS LATER THE NEW DEVICE ALERTED FOR HIGH PACING IMPEDANCE IN THE RV LEAD. THE RV LEAD WAS FOUND TO HAVE INTERMITTENT CAPTURE AT HIGH OUTPUT IN BIPOLAR MODE PACING FROM RV TIP TO RV RING. WHEN THE RV LEAD WAS RECONFIGURED TO RV TIP TO RV COIL, THE THRESHOLD WAS STABLE AND HAD DECREASED. THE LEAD WAS SUSPECT OF A POSSIBLE FRACTURE. THE PHYSICIAN AGAIN, ELECTED TO JUST LEAVE THE RV LEAD IN USE WITH THE RV TIP TO RV COIL CONFIGURATION AND MONITOR THE LEAD. A FEW WEEKS LATER, THE RV LEAD SHOWED HIGH PACING IMPEDANCE AND HIGH CAPTURE THRESHOLDS DURING A DEVICE CHECK AT THE CLINIC. THE PHYSICIAN DECIDED TO EXTRACT THE RV LEAD AND DURING THE LEAD EXTRACTION, THE PHYSICIAN NOTICED UPON INSPECTION THAT THE RV PACE/SENSE PORTION OF THE LEAD WAS NOT SEATED COMPLETELY IN THE HEADER. THE PHYSICIAN SUSPECTED THAT THE CAUSE OF THE HIGH IMPEDANCE WAS THAT THE LEAD WAS NOT SEATED PROPERLY IN THE HEADER. THE RV LEAD WAS EXTRACTED AND A NEW RV LEAD WAS IMPLANTED. THE LV LEAD AND DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644623 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419478

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR 5076-52 LEAD