BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON C 16-CHANNEL IPG

    MDR report key: 8130140 · Received December 4, 2018

    Report

    Report Number
    1627487-2018-12578
    Event Type
    Injury
    Date Received
    December 4, 2018
    Date of Event
    November 7, 2018
    Report Date
    January 8, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    05414734402460
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE ASSOCIATED MDR 1627487-2018-12570 AND 1627487-2018-12572.

    Additional Manufacturer Narrative · 1

    CHANGED FOR CLARIFICATION ON DATES. ADDED MODEL 3688: SCS IPG. ADDED PMA/520(K) P010032. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2018 WHERE THEIR ORIGINAL IPG WAS REPLACED AND ADDITIONAL LEADS WERE PLACED. REPORTEDLY, EFFECTIVE THERAPY WAS OBTAINED POSTOPERATIVELY.

    Description of Event or Problem · 1

    IT WAS REPORTED SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2018 WHERE THE ORIGINAL IPG WAS REPLACED WITH A NEW MODEL DUE TO AN UNKNOWN REASON. REPORTEDLY, EFFECTIVE THERAPY WAS OBTAINED POSTOPERATIVELY (PLEASE REFERENCE MFR. REPORT#1627487-2018-12570 REGARDING THE LEADS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970260 EON C 16-CHANNEL IPG SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3688 3389111 05414734402460

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other (B)(4)