BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2023225 · Received February 15, 2011

    Report

    Report Number
    1627487-2011-00335
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 3. REFERENCE MFR REPORT #S 1627487-2011-00336 AND 1627487-2011-00337. THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2009 INCLUDING AN IPG AND THREE PERCUTANEOUS LEADS. IT WAS REPORTED THAT THE PT IS WITHOUT STIMULATION. SEVERAL OF HER LEAD CONTACTS ARE EXHIBITING INVALID IMPEDANCE READINGS. ATTEMPTS TO RECAPTURE STIMULATION USING THE VALID CONTACTS PROVED UNSUCCESSFUL. AN X-RAY OF THE PT'S SCS SYSTEM WAS TAKEN; HOWEVER, NO VISIBLE ANOMALIES WERE OBSERVED. SURGICAL INTERVENTION WILL BE UNDERTAKEN TO RECTIFY THIS MATTER, BUT A DATE FOR THE PROCEDURE HAS NOT BEEN SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG, 16-CHANNEL RECHARGEABLE TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION DIV. 3788 2865284

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention