BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG

    MDR report key: 2100788 · Received May 19, 2011

    Report

    Report Number
    1627487-2011-01542
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 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
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RESULTS: AN ATTEMPT WAS MADE TO PROGRAM THE IPG BUT WAS UNSUCCESSFUL. THE IPG WAS AUTO-TESTED AND FAILED MULTIPLE TESTS, INCLUDING THE UCOD TEST. MANUAL TESTING WAS ALSO PERFORMED, BUT NO OUTPUTS WERE OBSERVED. 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 2. REFERENCE MFR REPORT: 1627487-2011-01543. THE PT ((B)(6)) RECEIVED HER SCS SYSTEM, INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS, IN (B)(6) 2006. IT WAS REPORTED THAT THE PT TURNED OFF HER SYSTEM TO HAVE AN MRI. AFTER THE PROCEDURE, SHE REPORTED THAT SHE BEGAN HAVING THE FOLLOWING ISSUES: INTERMITTENT STIMULATION, LONG RECHARGE CYCLES, AND AN INABILITY TO RECHARGE THE IPG. DIAGNOSTIC TESTS EXHIBITED HIGH IMPEDANCE MEASUREMENTS FOR MULTIPLE LEAD CONTACTS, AND ALL LEAD CONTACTS MEASURED INVALID. INTRAOPERATIVE TESTING OF HER LEADS WAS CONDUCTED AND SHOWED ALL LEAD CONTACTS WERE LOW WITH THE EXCEPTION OF TWO LEAD CONTACTS, WHICH SHOWED HIGH IMPEDANCE READINGS. STIMULATION WAS REPORTED AS CONSISTENT AND EFFECTIVE DURING INTRAOPERATIVE TESTING. THE PHYSICIAN DECIDED TO EXPLANT ONLY THE IPG AND REPLACED IT WITH A SMALLER MODEL 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 3716 47067

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| MODEL: 3383, SCS EXTENSION| IMPLANTED: