BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA VDD

    MDR report key: 3151570 · Received June 7, 2013

    Report

    Report Number
    3002807576-2013-00006
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED NO ANOMALIES. HOWEVER, THE RETURNED DEVICE INDICATED A DAMAGED GROMMET. FOREIGN MATERIAL WAS ON THE SET SCREW AND THE SET SCREW WAS MISALIGNED.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE PHYSICIAN WAS UNABLE TO SECURE THE IMPLANTABLE PACING LEAD TO THE IMPLANTABLE PULSE GENERATOR (IPG) BECAUSE OF A SET SCREW/GROMMET PROBLEM. THE DEVICE WAS NOT IMPLANTED AND WAS REPLACED BY ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252560 ADAPTA VDD PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND ADVDD01

    Patients

    Seq Age Sex Outcome Treatment
    1