BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA VDD

    MDR report key: 2813475 · Received October 31, 2012

    Report

    Report Number
    3008973940-2012-00047
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    Z-2120-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS ATRIAL OVERSENSING. DURING THE LEAD REVISION PROCEDURE, THE LEAD WAS MEASURED THROUGH THE ANALYZER AND INDICATED NO ANOMALY. THE LEAD WAS ABANDONED AND THE PHYSICIAN REQUESTED ANALYSIS ON THE IMPLANTABLE PULSE GENERATOR (IPG). A NEW ATRIAL LEAD AND DEVICE WERE IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA VDD IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC SINGAPORE OPERATIONS ADVDD01

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R