BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EONMINI IPG 16 CHANNEL IPG

    MDR report key: 2201179 · Received July 29, 2011

    Report

    Report Number
    1627487-2011-07003
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 27, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER IS INCLUDED IN (B)(4). 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

    ON (B)(6) 2011, IT WAS REPORTED BY THE PT THAT THERE WAS STIMULATION, HOWEVER, AFTER CHARGING FOR ABOUT 5 MINUTES (WITH THE RAPID FLASHING GREEN LIGHT) THE CHARGER LOSES COMMUNICATION. PT MENTIONED A RECENT WEIGHT LOSS WHICH MAY IMPACT THE EFFECT OF THE DEVICE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EONMINI IPG 16 CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2829840

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3189 (2)