BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 3861171 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07385
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 MEDICAL PRODUCTS: 6947-M55 LEAD, (B)(6) 2013; 5076-45 LEAD, (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY- THE FULL LEAD WAS RETURNED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CHRONIC LEFT VENTRICULAR (LV) LEAD DISLODGED FROM THE LATERAL VEIN OFF THE CORONARY SINUS. THE PHYSICIAN ATTEMPTED TO IMPLANT THE 1ST REPLACEMENT LV LEAD HOWEVER, IT DISLODGED FROM THE TARGET VESSEL AND WAS REMOVED AFTER MULTIPLE REPLACEMENT ATTEMPTS. THE PHYSICIAN ATTEMPTED TO IMPLANT THE 2ND REPLACEMENT LV LEAD HOWEVER, WAS NOT ABLE TO CANNULATE THE TARGET VESSEL. THE PHYSICIAN ATTEMPTED TO IMPLANT A 3RD LV LEAD HOWEVER, WAS UNABLE TO CANNULATE THE TARGET VESSEL. THE PHYSICIAN PLANNED FOR AN EPICARDIAL PLACEMENT AT A LATER DATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341694 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419488

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR D314TRM ICD