BEUDAMED
    FDA Adverse Event Injury Summary report: N

    50CM IMPLANT LEAD KIT, SLIM TIP

    MDR report key: 8438569 · Received March 20, 2019

    Report

    Report Number
    1627487-2019-03684
    Event Type
    Injury
    Date Received
    March 20, 2019
    Date of Event
    March 3, 2019
    Report Date
    April 30, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    PMP
    UDI-DI
    05415067025531
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS, METHOD AND CONCLUSION CODES ALONG WITH THE INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    DEVICE 2 OF 2, MFG REPORT REFERENCE: 1627487-2019-03683. FOLLOW UP INFORMATION RECEIVED. THE PATIENT HAD REPLACEMENT SURGERY ON (B)(6) 2019. EFFECTIVE THERAPY WAS RESTORED POST OPERATION.

    Description of Event or Problem · 1

    DEVICE 2 OF 2, MFG REPORT REFERENCE: 1627487-2019-03683. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. THE PATIENT STATED HAVING INCREASED PAIN. A X-RAY WAS TAKEN AND IT SHOWED LEAD MIGRATION. THE PATIENT TURNED OFF HER THERAPY AND PLANS TO UNDERGO SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    DEVICE 2 OF 2, MFG REPORT REFERENCE: 1627487-2019-03683.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230541 50CM IMPLANT LEAD KIT, SLIM TIP DRG LEAD PMP ST. JUDE MEDICAL - NEUROMODULATION MN10450-50A AB2382 05415067025531

    Patients

    Seq Age Sex Outcome Treatment
    1 Other