BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 3862106 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11110
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE ANALYSIS PERFORMED REVEALED NO ANOMALIES AND NO ISSUE WAS IDENTIFIED THAT REQUIRED FULL ANALYSIS.

    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: 2008 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A CHRONIC FEVER AND SEPSIS INFECTION. THE PHYSICIAN DECIDED TO REMOVE THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM IN ASSUMPTION THE SYSTEM WAS THE SOURCE OF THE INFECTION. THE IPG SYSTEM WAS REMOVED AND NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343331 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 407652 LEAD