BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA CRT-P

    MDR report key: 3992239 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01988
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P010015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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. CONTINUATION: 4076-52 LEAD 2014-(B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STATED THEY "RECENTLY FELT THE HEART DEVICE LIKE "MUSCLE TWITCH" AND THEY WEREN'T SURE WHAT THAT WAS." THE PATIENT INDICATED THEY HAD NEVER FELT IT BEFORE. THE DEVICE 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
    471172 CONSULTA CRT-P PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND C4TR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR 4076-58 LEAD