BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 3071704 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05304
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    February 14, 2013
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #THE FULL LEAD WAS RETURNED, ANALYZED AND THERE WERE NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE L EADINDICATED APPARENT EXPLANT DAMAGE, ALONG WITH STRETCHING.

    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. THERE WERE NO ANOMALIES FOUND. CONCOMITANT PRODUCTS: C154DWK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (B)(6) 2009; 5076 IMPLANTABLE PACING LEAD (B)(6) 2007; 0184 COMPETITOR IMPLANTABLE TACHY LEAD (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS CAUSING DIAPHRAGMATIC STIMULATION IN ALL CONFIGURATIONS AT OUTPUT OF THRESHOLDS. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172686 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419488

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Hospitalization| R