BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 7075152 · Received December 1, 2017

    Report

    Report Number
    1627487-2017-07916
    Event Type
    Injury
    Date Received
    December 1, 2017
    Date of Event
    November 6, 2017
    Report Date
    December 1, 2017
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER 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. THE MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR. REPORT:1627487-2017-07917. IT WAS REPORTED THE PATIENT EXPERIENCED SEVERE CHEST PAIN AND PAIN SHOOTING DOWN HER RIGHT ARM IN PACU AFTER UNDERGOING IPG AND LEAD IMPLANT. THE PATIENT WAS TRANSPORTED TO THE ER FOR FURTHER EVALUATION OF THE CARDIAC EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856142 PENTA 3MM LEAD, 60 CM SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 6089178

    Patients

    Seq Age Sex Outcome Treatment
    1 Other