BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVISA DR

    MDR report key: 3071781 · Received April 22, 2013

    Report

    Report Number
    9614453-2013-01031
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    February 7, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND, THE RETURNED DEVICE INDICATED THE SET SCREW WAS FOUND IN THE CONNECTOR BORE.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #GEO EVENT DESCRIPTION: IT WAS REPORTED THAT BEFORE IMPLANT THE PACEMAKER WAS PROGRAMMED TO BIPOLAR BUT NO PACING OCCURRED WHEN LEAD-PIN WAS INSERTED AND SET SCREW WAS TIGHTENED. THE LEAD-PIN WAS REMOVED AND REINSERTED BUT THERE WERE DIFFICULTIES GETTING THE SET-SCREW TIGHTENED TO THE LEAD. PRELIMINARY GEO ASSESSMENT: PRELIMINARY GEO CONCLUSION: LIKELY RELATED TO PROCEDURE/HANDLING (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 DURING THE IMPLANT ATTEMPT, THERE WAS NO PACING WHEN THE LEAD PIN WAS INSERTED AND THE SET SCREW TIGHTENED. THE LEAD WAS REMOVED AND REINSERTED. THE PHYSICIAN THEN HAD DIFFICULTIES GETTING THE SET SCREW TO TIGHTEN ON THE LEAD. THE DEVICE WAS NOT USED AND A NEW DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172826 ADVISA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND A3DR01

    Patients

    Seq Age Sex Outcome Treatment
    1