BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 2791082 · Received October 15, 2012

    Report

    Report Number
    3008973940-2012-00041
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 7, 2012
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    Z-2120-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 AND ANALYSIS FOUND NO ANOMALIES. HOWEVER, A GROMMET WAS DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE IMPLANT PROCEDURE, THE DEVICE HAD NO OUTPUT AND SHOWED OVERSENSING WHEN CONNECTED. THERE WAS EVIDENCE OF BLOOD IN THE HEADER OF THE DEVICE. THE DEVICE WAS NOT IMPLANTED AND ANOTHER DEVICE WAS USED. 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 DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC SINGAPORE OPERATIONS ADDR03

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other 5054 IMPLANTABLE PACING LEAD| 5554 IMPLANTABLE PACING LEAD