BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSURA DR MRI SURESCAN

    MDR report key: 3153413 · Received June 8, 2013

    Report

    Report Number
    6000094-2013-00052
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 28, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    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 SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE RETURNED DEVICE WAS INCONCLUSIVE. PRELIMINARY ANALYSIS REVEALED A NO OUTPUT AND NO TELEMETRY CONDITION. THE DATA GATHERED DURING THE VISUAL AND DIMENSIONAL INSPECTION OF THE DEVICE BATTERY INDICATED THAT THE BATTERY WAS SWOLLEN, HAVING A THICKNESS ABOVE THE UPPER SPECIFICATION LIMIT. THE SWELLING WAS MOST LIKELY CAUSED BY AN EXTERNAL SHORT OR OTHER MISHANDLING CONDITION, SINCE THERE IS NO EVIDENCE OF AN INTERNAL PROBLEM CAUSING THE SWELLING. NO EVIDENCE OF AN INTERNAL MECHANISM FOR PREMATURE DEPLETION WAS FOUND DURING DESTRUCTIVE ANALYSIS. NO PROBLEMS WERE FOUND WITH THE BATTERY. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST IMPLANT OF THE DEVICE THERE WAS NO TELEMETRY BETWEEN THE DEVICE AND THE PROGRAMMER AND THE DEVICE DID NOT PACE. THEREFORE, THE DEVICE WAS REMOVED AND REPLACED WITH A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256500 ENSURA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND EN1DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R