BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3012159 · Received March 13, 2013

    Report

    Report Number
    1627487-2013-13273
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    DEVICE 1 OF 2: REFERENCE MFR. REPORT: 1627487-2013-13274. IT WAS REPORTED THE PATIENT WAS EXPERIENCING PERSISTENCE PAIN IN HIS RIGHT FLANK AREA WHEN HIS STIMULATION WAS TURNED OFF. THE PATIENT STATED THE PAIN HAD GOTTEN WORSE WHEN THE STIMULATION WAS ON. THE PATIENT DECLINED BEING REPROGRAMMED. FOLLOW-UP INFORMATION IDENTIFIED THE PATIENT WAS SEEN ON (B)(6) 2013 BY A NURSE PRACTITIONER TO REMOVE HIS STAPLES. THE PATIENT HAD SWELLING AT THE KNEE AND WEAKNESS IN HIS RIGHT LEG. THE PATIENT WAS ALSO COMPLAINING ABOUT PAIN. X-RAYS WERE TAKEN AND CONFIRMED THE PATIENT'S LEAD HAD NOT MIGRATED. REPROGRAMMING WAS ABLE TO CAPTURE STIMULATION IN THE PATIENT'S LEFT LEG. THE PATIENT HAD GOTTEN "JOLTED" WHEN PROGRAMMING WAS TRIED USING CONTACTS 3-6. THE PATIENT'S PHYSICIAN OPTED TO EXPLANT THE ENTIRE SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106496 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3768682

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention