BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-P

    MDR report key: 3861774 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01418
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 28, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    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 MEDICAL PRODUCTS: A 4968-60 LEAD, (B)(6) 2013. A 4938-35 LEAD, (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY-THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND THERE WAS UNEXPECTED BATTERY LONGEVITY HOWEVER, IT WAS NOTED HIGH OUTPUTS WERE USED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340137 CONSULTA CRT-P PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND C4TR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00028 YR Hospitalization| R 4968-35 LEAD