BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA S

    MDR report key: 2203182 · Received August 11, 2011

    Report

    Report Number
    6000094-2011-01414
    Event Type
    Injury
    Date Received
    August 11, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) HAD A CAPTURE MANAGEMENT FUNCTION PROBLEM. THERE WAS HIGH DIFFERENCE IN MANUAL AND AUTOMATIC MEASUREMENT OF THE THRESHOLD. THE PHYSICIAN SWITCHED OFF CAPTURE MANAGEMENT AND REPROGRAMMED OUTPUT. THE DEVICE REMAINS IN USE. 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 S IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. SES01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention