BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIA SR

    MDR report key: 2953437 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00227
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    January 29, 2013
    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

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NEARING ELECTIVE REPLACEMENT INDICATOR AND PREMATURE BATTERY DEPLETION WAS SUSPECTED. A REVIEW OF THE DEVICE PRODUCT PERFORMANCE INFORMATION NOTED THAT THE DEVICE HAD A PROGRAMMED OUTPUT OF 5V AND 1 MS WHICH WOULD CAUSE FASTER DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57835 RELIA SR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND RESR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| R