BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA SR

    MDR report key: 2202247 · Received August 11, 2011

    Report

    Report Number
    6000094-2011-01351
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 2, 2011
    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
    AR
    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 ANALYSIS FOUND NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT THE DEVICE HAD CONNECTOR PROBLEMS. THE DEVICE WAS NOT IMPLANTED AND ANOTHER DEVICE WAS USED. 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 SR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. SESR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other