BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSURA DR MRI SURESCAN

    MDR report key: 3990504 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01787
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 27, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT MEDICAL PRODUCTS: A 5076-58 LEAD, IMPLANTED: (B)(6) 2014. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY # PRODUCT ID# (B)(4). THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND, THE RETURNED DEVICE INDICATED A LOOSE/DETACHED SET SCREW.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SCREW DRIVER COULD NOT BE USED IN THE SCREW OF THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED. ALSO REPORTED WAS THAT SENSING ON THE LEAD WAS NOT STABLE ON THE DATE OF IMPLANT AND THE LEAD WAS REPOSITIONED. THE LEAD REMAINS IN USE AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468573 ENSURA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND EN1DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention 5076-52 LEAD