BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENRHYTHM

    MDR report key: 3050976 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05905
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    January 16, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE PATIENT HAS ATRIAL TACHYCARDIA (AT) AND ATRIAL FIBRILLATION (AF). PATIENT ALSO REPORTED HAVING "SKIPPED BEATS". PATIENT INDICATED THEY HAD FELT AF AND AT AND THE PHYSICIAN DID NOT FIND THAT INFORMATION RECORDED IN THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT FEELS THAT THE IPG IS NOT "GETTING ALL OF THE RHYTHMS". ADDITIONAL INFORMATION WAS ATTEMPTED TO BE OBTAINED, HOWEVER, IT WAS NOT AVAILABLE. THE IPG 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
    153035 ENRHYTHM PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) IMPLANTABLE PACING LEAD