BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY MRI IPG, US PR

    MDR report key: 8962375 · Received September 4, 2019

    Report

    Report Number
    3006705815-2019-03385
    Event Type
    Injury
    Date Received
    September 4, 2019
    Date of Event
    June 5, 2019
    Report Date
    September 12, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    UDI-DI
    05415067017086
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    (REFERENCE REG NUMBER: 1627487-2019-07243) (REFERENCE REG NUMBER 1627487-2019-07244) IT WAS REPORTED THE SCRUB TECH REMOVED THE IPG FROM THE STERILE FIELD, WHEREIN THE IPG BECAME UNSTERILE. AS A RESULT, DURING SURGICAL INTERVENTION THAT OCCURRED ON (B)(6) 2019 THE SCS IPG AND LEADS WERE EXPLANTED AND REPLACED. POSTOPERATIVELY, THE PATIENT HAS EFFECTIVE THERAPY AND IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755311 PRODIGY MRI IPG, US PR SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3772 A000035745 05415067017086

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL 3186, SCS LEAD (X2)