BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 3863203 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01325
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    April 14, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A DEVICE ALERT AND PATIENT WENT TO HOSPITAL FOR PROGRAMMING CHECK. ACCORDING TO THE PATIENT, THE DOCTOR SHUT DOWN SOME FUNCTION OF THE DEVICE. THE PATIENT FELT UNCOMFORTABLE AFTERWARDS (PATIENT FELT STIMULATION BY WAS NOT CONFIRMED BY CLINICIAN). THEN THE PATIENT WENT TO ANOTHER HOSPITAL FOR PROGRAMMING AGAIN AND THE DOCTOR ADJUSTED SOME PARAMETERS, AND PATIENT'S SYMPTOMS RELIEVED LATER. NOW THE PATIENT FEELS THE DEVICE BEATING DURING NIGHT, AND PATIENT CALLED THE HOTLINE TO ASK FOR PROGRAMMING AGAIN. FOLLOW UP CONFIRMED THE PATIENT WAS SEEN BY THE DOCTOR. THERE WAS HIGH LEFT VENTRICULAR (LV) LEAD THRESHOLD FOUND WHEN THE DEVICE WAS INTERROGATED AND IT WAS ADJUSTED ACCORDINGLY. THE LV LEAD 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
    341190 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP IPG MFG SWITZERLAND 4193

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention 7285 ICD