BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-P

    MDR report key: 3992148 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01998
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. CONCOMITANT: 5086MRI45 LEAD IMPLANTED 2011-(B)(6); 4693-88 LEAD IMPLANTED 2014-(B)(6). (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT AFTER RECEIVING A NEW DEVICE AND LEFT VENTRICULAR (LV) LEAD, THEY EXPERIENCED INVOLUNTARY SPASMS AND ELEVATED HEART RATE. ACCORDING TO THE PATIENT, THEIR LV LEAD WAS TURNED OFF IN THE CLINIC, AS NO PROGRAMMING CHANGES WOULD ALLOW THE LEAD TO FUNCTION PROPERLY. IT WAS LATER CONFIRMED BY THE PATIENT'S CLINIC THAT THE DEVICE WAS REPLACED. THE LV LEAD REMAINS IN THE PATIENT. NO FURTHER INFORMATION WAS AVAILABLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471437 CONSULTA CRT-P PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND C4TR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| R 5086MRI52 LEAD