BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 2210711 · Received July 28, 2011

    Report

    Report Number
    1627487-2011-00998
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 29, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MR IS BEING SUBMITTED PAST THE 30-DAY REPORTING REQUIREMENT AS PART OF AN ADD'L RETROSPECTIVE REVIEW INITIATED IN RESPONSE TO THE (B)(6) 2011 FDA INSPECTION. WE ARE SUBMITTING THIS MDR AS THE RESULT OF A RE-EVAL OF OUR COMPLAINT PROCESS. SJM HAS LIMITED INFO RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2011-00999. ON (B)(6) 2010, THE PT WAS IMPLANTED WITH THE FIRST OF TWO SCS SYSTEMS WHICH INCLUDED AN IPG, FOUR PERCUTANEOUS LEADS AND TWO EXTENSIONS. IT WAS REPORTED THAT THE POCKET LOCATION FOR THE IPG WAS REVISED ON (B)(6) 2010 DUE TO THE PT'S WEIGHT LOSS. IN (B)(6) 2010, THE PT REPORTED EXPERIENCING A CYCLING SENSATION IN HER PROGRAMMING THAT RESULTS IN HEADACHES WHENEVER THE STIMULATION WAS FUNCTIONING. ON (B)(6) 2011, THE PT WAS IMPLANTED WITH A SECOND SCS SYSTEM WHICH INCLUDED AN IPG, FOUR PERCUTANEOUS LEADS AND TWO LEAD EXTENSIONS. THE REPORTED CYCLING ISSUE REMAINED. IN AN EFFORT TO DETERMINE THE ROOT CAUSE, A DIAGNOSTIC TEST WAS TAKEN. THE RESULTS REVEALED INVALID IMPEDANCE MEASUREMENTS ASSOCIATED WITH TWO OF THE LEADS FROM THE PT'S INITIAL SCS SYSTEM. THE ORIGINAL IPG WAS REPLACED ON (B)(6) 2011 AND ALTHOUGH THE IMPEDANCE ISSUE REMAINED FOLLOWING THE PROCEDURE, THE CYCLING SENSATION HAD REPORTEDLY DISSIPATED, AND THE PT WAS EXPERIENCING EFFECTIVE THERAPY RELIEF. F/U INFORMATION RECENTLY REC'D FROM THE PT INDICATES THAT THE CYCLING ISSUE AND THE RESULTING HEADACHES HAVE NOW RECURRED. SHE IS WORKING CLOSELY WITH HER IMPLANTING PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION IN THIS MATTER.

    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 3113023

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention IMPLANTED:| SCS LEAD EXTENSIONS: MODEL 3346 (2)| IMPLANTED:| SCS LEADS: MODEL 3149 (2)| IMPLANTED:| SCS IPG: MODEL 3176| SCS LEADS: MODEL 3169 (4)| IMPLANTED:| IMPLANTED:| SCS LEAD EXTENSIONS: MODEL 3346 (2)