BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 1862767 · Received October 8, 2010

    Report

    Report Number
    6000094-2010-01902
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 3, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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) NO ANOMALIES FOUND, HOWEVER SETSCREW AND GROMMET WERE NOTED TO BE DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEAD REPLACEMENT ATTEMPT, WHEN THE PHYSICIAN LOOSENED THE ATRIAL SETSCREW ON THE DEVICE HEADER, THE GROMMET SEPARATED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. ADDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention