BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA SR

    MDR report key: 2173939 · Received July 24, 2011

    Report

    Report Number
    6000094-2011-01288
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Date of Event
    July 1, 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
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. 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.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. 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, DURING THE IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG), THE PHYSICIAN FELT THAT THE CONNECTION OF THE LEAD INTO THE CONNECTOR WAS INADEQUATE. THE IPG WAS NOT IMPLANTED AND A NEW IPG 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 1 MO Other (B)(4) IMPLANTABLE PULSE GENERATOR ACCESSORY| (B)(4) IMPLANTABLE PULSE GENERATOR ACCESSORY| (B)(4) IMPLANTABLE PULSE GENERATOR ACCESSORY