BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA D

    MDR report key: 2812298 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02530
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 19, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    Z-2120-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    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 AND ANALYZED. NO ANOMALIES WERE FOUND. THE SET SCREW WAS NOTED WITH A ROUNDED SOCKET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE DEVICE HAD A PROBLEM WITH THE SETSCREW. THE DEVICE WAS REMOVED AND A NEW DEVICE WAS IMPLANTED INSTEAD. IT WAS ALSO NOTED THAT UPON RECEIPT OF THE DEVICE, NO TELEMETRY WAS POSSIBLE. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSIA D IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. SED01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other