BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 2121033 · Received June 9, 2011

    Report

    Report Number
    1627487-2011-00795
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    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

    EVAL: RESULTS: BASED ON THE EVENT DETAILS, THE PT DID NOT RECHARGE FOR ABOUT (B)(6). ACCORDING TO THE (B)(4), THERE IS ADEQUATE INFO FOR PRESERVING THE IPG BATTERY WHEN NOT IN USE. (B)(4) STATES THAT "WARNING: IF YOU DO NOT RECHARGE A DEPLETED IPG WITHIN (B)(6) (DEPENDING ON THE PROXIMITY TO THE END OF THE DEVICE LIFE), THE IPG MAY LOSE ITS ABILITY TO BE RECHARGED." 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 # 1627487-2011-00796. THE PT RECEIVED AN SCS SYSTEM INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS FROM THE SAME LOT FOR LOW BACK AND LEG PAIN. IT WAS REPORTED THAT SHE HAD BEEN WITHOUT STIMULATION FOR AT LEAST (B)(6). SHE ALLEGEDLY HAS NOT RECHARGED HER IPG SINCE (B)(6) 2010 AND AS SUCH CANNOT ESTABLISH COMMUNICATION WITH THE DEVICE VIA THE PROGRAMMER. WHEN HER THERAPY WAS FUNCTIONING, THE PT WAS SAID TO HAVE FELT STIMULATION IN HER ARMS AS WELL AS OCCASIONAL OVERSTIMULATION. AN X-RAY REVEALED THAT ONE OF THE PT'S LEADS MIGRATED. SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE PT'S LEAD AND IPG WHERE IT WAS DISCOVERED THAT THE LEAD HAD BECOME PARTIALLY DISCONNECTED FROM THE HEADER. NO FURTHER COMPLICATIONS WERE REPORTED.

    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 2807323

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention SCS LEAD ANCHORS: MODEL 1194| IMPLANTED: