BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 4161075 · Received October 10, 2014

    Report

    Report Number
    9614453-2014-02331
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 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
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED TANTALUM CAPACITOR SHORTING LOW RESISTANCE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY WERE UNABLE TO INTERROGATE THE IMPLANTABLE PULSE GENERATOR (IPG). THE DEVICE DID NOT RESPOND TO ANY INTERROGATION OR MAGNET. 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
    642458 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND ADDR03

    Patients

    Seq Age Sex Outcome Treatment
    1 00094 YR Hospitalization| R