BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPULSE SR

    MDR report key: 4429501 · Received January 16, 2015

    Report

    Report Number
    9614453-2015-00012
    Event Type
    Injury
    Date Received
    January 16, 2015
    Date of Event
    December 20, 2014
    Report Date
    January 29, 2015
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.

    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 ABDOMINAL IMPLANTABLE PULSE GENERATOR (IPG) HAD BEEN PREVIOUSLY TURNED OFF (OVO MODE) AND REPLACED WITH A TRANSVENOUS SYSTEM. A REQUEST WAS MADE TO HAVE THE DEVICE CHECKED AND IT WAS DETERMINED THAT THE ABDOMINAL DEVICE THAT REMAINED IN THE PATIENT'S BODY AND WAS NOW OPERATING VVI 65. IT WAS SUSPECTED THAT AN ELECTRICAL RESET HAD OCCURRED. THE PATIENT WAS HOSPITALIZED AT THE TIME THE SUSPECTED RESET HAD OCCURRED. THE CAUSE OF RESET WAS ASSUMED TO BE INTERFERENCE WITH OTHER MEDICAL DEVICES. HOWEVER THIS WAS NOT CONFIRMED. THE ABDOMINAL IPG WAS AGAIN PROGRAMMED OVO MODE AND WAS LATER EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41478 ENPULSE SR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND E2SR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00018 YR Hospitalization| R 4965-35 LEAD