BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA DR

    MDR report key: 2123184 · Received June 14, 2011

    Report

    Report Number
    6000094-2011-00711
    Event Type
    Injury
    Date Received
    June 14, 2011
    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 Occupation
    PHYSICIAN

    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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DID NOT STIMULATE WHEN THE PHYSICIAN PLACE TO MAGNET OVER THE DEVICE. THE PHYSICIAN PROGRAMMED TO HIGHER OUTPUTS BUT THE DEVICE STILL DID NOT STIMULATE. THE DEVICE WAS REMOVED 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
    1 SENSIA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. SEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R