BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY IPG

    MDR report key: 8903100 · Received August 16, 2019

    Report

    Report Number
    1627487-2019-09339
    Event Type
    Injury
    Date Received
    August 16, 2019
    Date of Event
    July 29, 2019
    Report Date
    October 7, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    05415067020260
    PMA / PMN Number
    P140009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED ON THE FINAL REPORT. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REPORT NUMBER 1627487-2019-09340. IT WAS REPORTED THAT DURING PROCEDURE, LEAD EXTENSION DAMAGE ISSUE WAS OBSERVED REPORTED IN MANUFACTURER REPORT NUMBER 1627487-2019-08944. THE END OF THE EXTENSION WAS LEFT IN THE IMPLANTABLE PULSE GENERATOR (IPG). THE IPG NINE-SIXTEEN HOLE WAS UNABLE TO BE OPENED RESULTING IN THE EXTENSION UNABLE TO BE INSERTED INTO THE IPG DUE TO SET SCREW ISSUE. A NEW EXTENSION USED DURING THE PROCEDURE, WAS DAMAGED DURING THE PROCEDURE AS WELL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694616 INFINITY IPG DBS IPG MHY ST. JUDE MEDICAL - NEUROMODULATION 6662 6835795 05415067020260

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DBS EXTENSION