BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 2172571 · Received July 20, 2011

    Report

    Report Number
    1627487-2011-06016
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    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

    THE PT WAS IMPLANTED WITH AN IPG ON (B)(6) 2010. IT WAS REPORTED THAT SHE WAS WITHOUT STIMULATION AND UNABLE TO COMMUNICATE WITH THE IPG VIA EITHER THE PROGRAMMER OR CHARGING SYSTEM. THE PT HAD REPORTEDLY EXPERIENCED TWO EVENTS IN WHICH THE IPG WAS INADVERTENTLY IMPACTED. COMMUNICATION ATTEMPTS WITH MULTIPLE PROGRAMMERS WERE UNSUCCESSFUL. X-RAYS WERE TAKEN; HOWEVER, NO VISIBLE ANOMALIES WERE OBSERVED. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2011 TO REPLACE THE PT'S IPG, AND EFFECTIVE STIMULATION WAS RECAPTURED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG, 16-CHANNEL TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3108319

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention IMPLANTED:| SCS LEAD: MODEL: 3186 (2)