BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 3071619 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05244
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    February 25, 2013
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  2009 (B)(6); 6948 IMPLANTABLE TACHY LEAD 2006 (B)(6); 5076 IMPLANTABLE PACING LEAD 2006 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4). THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD PREMATURE BATTERY DEPLETION. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD HIGH THRESHOLD AND THE LEFT VENTRICULAR (LV) LEAD WAS DISLODGED AND HAD HIGH THRESHOLD. IT WAS LATER NOTED THAT THE PHYSICIAN FELT THE BATTERY DEPLETION MAY HAVE BEEN "NORMAL" DUE TO THE HIGH THRESHOLD ON THE LEADS. THE ICD, RA AND LV LEADS WERE 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
    172404 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 4194

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Hospitalization| R