BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 3152349 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06852
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    April 10, 2013
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY FRACTURED DUE TO MELTING, THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO MELTING AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. THE ANALYST COMMENTED THAT THE LEAD WAS RETURNED WITH SEVERE EXPLANT DAMAGE AND THERE WERE NO OTHER ANOMALIES THAT WOULD CONTRIBUTE TO HIGH THRESHOLD. CONCOMITANT PRODUCTS: 5076 X2 IMPLANTABLE PACING LEADS 2011 (B)(6).

    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 PRODUCT: 5276 X2 IMPLANTABLE PACING LEADS: (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH THRESHOLD. THEREFORE THE LV LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252943 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419488

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R C4TR01 IMPLANTABLE PACEMAKER CARDIO/DEFIB