BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY IPG

    MDR report key: 5878991 · Received August 16, 2016

    Report

    Report Number
    1627487-2016-04183
    Event Type
    Injury
    Date Received
    August 16, 2016
    Report Date
    September 18, 2016
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULAITON
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SJM HAS LIMITED INFORMATION 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. (B)(4).

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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.

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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

    IT WAS REPORTED THE PATIENT ((B)(6)) EXPERIENCED DISCOMFORT AT THE IPG SITE (DESCRIBED AS HEATING). FOLLOW-UP REVEALED SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2016 DURING WHICH TIME THE IPG WAS EXPLANTED. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: LEAD(S) MODEL/IMPLANT DATES UNKNOWN.

    Description of Event or Problem · 1

    FOLLOW-UP IDENTIFIED MODEL 3186 AS THE CONCOMITANT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530279 PRODIGY IPG SCS IPG LGW ST. JUDE MEDICAL NEUROMODULAITON 3799 5249899

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other