BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 2073293 · Received May 1, 2011

    Report

    Report Number
    6000094-2011-00658
    Event Type
    Injury
    Date Received
    May 1, 2011
    Report Date
    December 18, 2024
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PEDIATRIC PATIENT PRESENTED WITH DIZZINESS AND THERE WAS A SUSPECTED LEAD FRACTURE. NO FRACTURE WAS SEEN ON XRAY AND THE PATIENT WAS BEING PREPPED FOR REPLACEMENT WHEN AN INTERROGATION WAS DONE INDICATING NORMAL FUNCTION. THE LEAD THRESHOLDS AND SENSING WERE TESTED WITH ACCEPTABLE VALUES. IT WAS FURTHER REPORTED THAT THE PHYSICIAN DECIDED NOT TO REPLACE THE LEAD AND IT IS STILL IN USE. IT WAS FURTHER REPORTED THAT THERE WAS NOISE, A PAUSE IN DEVICE TRACKING AND NO PACING OUTPUT. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. ADDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Male Life Threatening| H| R 4968 IMPLANTABLE PACING LEAD.| 4968 IMPLANTABLE PACING LEAD