BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA DR

    MDR report key: 4161080 · Received October 10, 2014

    Report

    Report Number
    3008973940-2014-00387
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    June 24, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COMPETITOR LEAD REVISION PROCEDURE, THE PATIENT EXPERIENCED STIMULATION OF THE PECTORAL MUSCLE ONCE THE LEAD WAS CONNECTED TO THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED, WHICH WAS REPORTED TO RESOLVE THE STIMULATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642529 SENSIA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC SINGAPORE OPERATIONS SEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R