BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 2955171 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-00803
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    November 27, 2012
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.EVALUATION SUMMARY: THE LEAD WAS NOT RETURNED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. PATIENT ALERTS FOR LEFT VENTRICULAR (LV) LEAD IMPEDANCE GREATER THAN 2500 OHMS ON (B)(6) 2005. THE WEEKLY PACING LEAD TREND DATA SHOWS AN ABRUPT INCREASE FROM MINIMUM AND MAXIMUM LV PACING OF 488 TO 16382 OHMS PEAK BETWEEN (B)(6) 2005.THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. (B)(4).

    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 PATIENT'S LEFT VENTRICULAR (LV) LEAD WAS DISLODGED. THE LEAD WAS REPOSITIONED AND REMAINED IN USE. ABOUT E IGHTEEN MONTHS LATER, THE LV LEAD FRACTURED. THE LV LEAD WAS REPAIRED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58284 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 4193

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| R 7304 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)