BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA DR

    MDR report key: 1854971 · Received October 5, 2010

    Report

    Report Number
    6000094-2010-01774
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    August 11, 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
    GB
    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 TO THE MANUFACTURER, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATTEMPT TO CONNECT THE CHRONICALLY IMPLANTED LEADS TO THE NEW DEVICE THE PHYSICIAN COMMENTED THAT HE DID NOT HEAR THE "CLICKING SOUND" THE WRENCH NORMALLY MAKES WHEN TIGHTENING THE SET SCREW. THE PHYSICIAN THEN UNSCREWED THE SET SCREW AND TRIED TO REMOVE THE LEAD FROM THE PACEMAKER, BREAKING OFF THE LEAD'S CONNECTOR PIN INSIDE THE PACEMAKER. THE PACEMAKER WAS NOT IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATTEMPT TO CONNECT THE CHRONICALLY IMPLANTED LEADS TO THE NEW DEVICE THE PHYSICIAN COMMENTED THAT HE DID NOT HEAR THE CLICKING SOUND THE WRENCH NORMALLY MAKES WHEN TIGHTENING THE SET SCREW. THE PHYSICIAN THEN UNSCREWED THE SET SCREW AND TRIED TO REMOVE THE LEAD FROM THE PACEMAKER, BREAKING OFF THE LEAD'S CONNECTOR PIN INSIDE THE PACEMAKER. THE PACEMAKER WAS NOT IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSIA DR ASKU NVZ MEDTRONIC S.A. SEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ELA COMPETITOR IMPLANTABLE PACING LEAD| ELA COMPETITOR IMPLANTABLE PACING LEAD