BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA

    MDR report key: 2951681 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00056
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    October 31, 2012
    Report Date
    November 2, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE SETSCREW WAS IN THE CONNECTOR BORE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SET SCREW IN THE PACEMAKER HEADER WAS NOT IN THE RIGHT POSITION. IT WAS NOT POSSIBLE TO PLACE THE LEAD CONNECTOR PIN IN THE HEADER. THE ISSUE COULD NOT BE SOLVED BY TURNING THE SCREW. US: IT WAS REPORTED THAT DURING IMPLANT, THE DEVICE SETSCREW "WAS NOT IN THE RIGHT POSITION" AS IT WAS NOT POSSIBLE TO PUT THE LEAD PIN IN THE HEADER. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE DEVICE SETSCREW "WAS NOT IN THE RIGHT POSITION" AS IT WAS NOT POSSIBLE TO PUT THE LEAD PIN IN THE HEADER. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE DEVICE SETSCREW "WAS NOT IN THE RIGHT POSITION" AS IT WAS NOT POSSIBLE TO PUT THE LEAD PIN IN THE HEADER. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55629 SENSIA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND SESR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR