BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA S

    MDR report key: 1922878 · Received December 13, 2010

    Report

    Report Number
    6000094-2010-02228
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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.

    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 ANALYSIS REVEALED NO ANOMALIES. HOWEVER, THE SET SCREW WAS DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A POSSIBLE SETSCREW PROBLEM. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A POSSIBLE SETSCREW PROBLEM. THE DEVICE WAS EXPLANTED AND RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SETSCREW ISSUE APPEARED DURING THE IMPLANT PROCEDURE. NO PATIENT COMPLICATIONS WERE 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 Other