BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 4925879 · Received July 20, 2015

    Report

    Report Number
    1627487-2015-12384
    Event Type
    Injury
    Date Received
    July 20, 2015
    Report Date
    June 25, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED AT THE EMERGENCY ROOM DUE TO URINARY AND BOWEL INCONTINENCE AND WEAKNESS IN THE LEGS AFTER STIMULATION WAS TURNED ON. A CT MYELOGRAM WAS DONE AND SHOWED NO ANOMALIES. THE SCS SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469389 PENTA 3MM LEAD, 60 CM SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 5053314

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL 3789, SCS IPG