BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPULSE DR

    MDR report key: 3861323 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01453
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    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 THAT THE PATIENT PRESENTED TO THE HOSPITAL COMPLAINING OF DIZZINESS. IT WAS DETERMINED THAT THE VENTRICULAR ESCAPE RHYTHM WAS 30 BEATS PER MINUTE. IN ADDITION, THERE WAS NO CAPTURE NOTED ON THE ELECTROCARDIOGRAM (ECG). IT WAS MENTIONED THAT THE DEVICE WAS UNABLE TO BE INTERROGATED. UNEXPECTED BATTERY DEPLETION IS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED SUCCESSFULLY. AFTER EXPLANT, THE DEVICE WAS ABLE TO BE INTERROGATED WITH A REMAINING LONGEVITY OF 8 MONTHS ESTIMATED. IT WAS NOTED THAT THE DEVICE HAD NOT YET REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340652 ENPULSE DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND E2DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Hospitalization| R