BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG

    MDR report key: 2051550 · Received April 7, 2011

    Report

    Report Number
    1627487-2011-01354
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 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
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-01355. THE PT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG AND SURGICAL LEAD ON (B)(6) 2006. IT WAS REPORTED THAT THE PT'S LEAD EXHIBITED INVALID IMPEDANCE READINGS ON ALL LEAD CONTACTS. THE PT REPORTED NO RECENT TRAUMATIC EVENTS OR FALLS. IT WAS ALSO REPORTED THAT THE PT WAS UNABLE TO RECHARGE HER IPG. THE PT STATED THAT HER IPG HAD NOT WORKED IN A LONG TIME. IT WAS UNK WHETHER THE PT HAD TRIED A REPLACEMENT CHARGING SYSTEM. THE PHYSICIAN EXPLANTED AND REPLACED THE PT'S IPG AND LEAD ON (B)(6) 2011. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIV 3716 55418

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention