BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIA S

    MDR report key: 3862388 · Received June 10, 2014

    Report

    Report Number
    3008973940-2014-00204
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 22, 2014
    Report Date
    March 22, 2014
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 THE IMPLANT PROCEDURE THE SET SCREW FOR THE DEVICE "CAME OUT." THE PHYSICIAN DID NOT WANT TO USE THE DEVICE AND IMPLANTED A NEW DEVICE. IT WAS FURTHER REPORTED THAT WITHIN TWELVE HOURS OF THE PROCEDURE THE TINED LEAD BECAME DISLODGED AND HIGH THRESHOLD WAS FOUND. THE LEAD WAS EXPLANTED AND A NEW SCREW-IN LEAD 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
    338484 RELIA S PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC SINGAPORE OPERATIONS RES01

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR 4092-58, LEAD