BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3850632 · Received May 29, 2014

    Report

    Report Number
    1627487-2014-15412
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 29, 2014
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2014-15413. IT WAS REPORTED, THE PT LOST STIMULATION AFTER FALLING DOWN STAIRS. REPROGRAMMING WAS UNABLE TO PROVIDE EFFECTIVE STIMULATION AND THE PT WAS EXPERIENCING UNINTENDED ABDOMINAL AND RIB STIMULATION. IMPEDANCE VALUES WERE WITHIN NORMAL LIMITS. THE PT ALSO EXPERIENCES DISCOMFORT AT THE IPG SITE DUE TO THE LOCATION OF THE IPG. THE PT IS TO CONSULT WITH HER PHYSICIAN REGARDING UNDERGOING SURGICAL INTERVENTION AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317194 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3865888

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other