BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-P

    MDR report key: 3864925 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01482
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 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
    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. PRODUCTS: 407645 LEAD IMPLANTED: 2013 (B)(6); 3778-60 X 2 PAIN STIM LEAD IMPLANTED: 2007 (B)(6); 37742 NEURO PROGRAMMER IMPLANTED: 2007 (B)(6); 37711 PAIN STIM IPG IMPLANTED: 2007 (B)(6); 429688 LEAD IMPLANTED: 2013 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING THRESHOLDS WITH INTERMITTENT CAPTURE. ALSO, THE IMPLANTABLE PULSE GENERATOR (IPG) EXPERIENCED UNEXPECTED LONGEVITY. THE LEAD AND DEVICE WERE 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
    340542 CONSULTA CRT-P PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND C4TR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| R 407658 LEAD