BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIA DR

    MDR report key: 4161725 · Received October 10, 2014

    Report

    Report Number
    3008973940-2014-00364
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED NO ANOMALIES WERE FOUND, AND THE RETURNED DEVICE INDICATED A MISSING SET SCREW.

    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).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW COULD NOT COME OUT OF THE IMPLANTABLE PULSE GENERATOR (IPG) WITH THE PRODUCT SCREWDRIVER. HOWEVER, THE SCREW WAS ABLE TO BE REMOVED OUT OF THE IPG WITH A NON MEDTRONIC SCREWDRIVER. THE IPG WAS REMOVED AND REPLACED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639269 RELIA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC SINGAPORE OPERATIONS REDR01

    Patients

    Seq Age Sex Outcome Treatment
    1