BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2153364 · Received June 30, 2011

    Report

    Report Number
    1627487-2011-01696
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THE PT (B)(6) RECEIVED HER SCS SYSTEM ON (B)(6) 2009. THE PT'S LEAD LOCATIONS ARE LATERAL AND MEDIAL RIGHT KNEE. IT WAS REPORTED THAT THE PT WAS IN A CAR ACCIDENT, AND HER CAR DOOR HIT HER RIGHT LEG WHEN IT WAS STRUCK BY ANOTHER CAR. SINCE THE ACCIDENT, THE PT COMPLAINED OF PAIN AND SWELLING, AND SHE WAS UNABLE TO USE THE SYSTEM. X-RAYS SHOWED NO EVIDENCE OF LEAD MIGRATION OR DAMAGE, AND DIAGNOSTIC TESTS REVEALED NO ANOMALIES. THE PT WAS REPROGRAMMED WHEN HER SWELLING DIMINISHED, BUT SHE REPORTED OVERSTIMULATION AT ALL FOUR LEADS DURING THE SESSION. THE PROGRAMMING SESSION WAS ABORTED. THE PT PLANS TO CONSULT WITH HER PHYSICIAN REGARDING THE NEXT COURSE OF ACTION. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2775351

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANT:| SCS LEAD ANCHOR: MODEL: 1194| IMPLANT:| SCS LEAD: MODEL: 3153 X 4