BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3850385 · Received May 15, 2014

    Report

    Report Number
    1627487-2014-26406
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 24, 2014
    Report Date
    February 12, 2016
    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

    IT WAS REPORTED THE PT WAS EXPERIENCING EXCRUCIATING PAIN AT HER PADDLE LEAD SITE BETWEEN HER SHOULDER BLADES. THE PT ALSO EXPERIENCES PAIN AT THE SURGICAL SITE WHEN STIMULATION IS TURNED ON. A CT SCAN HAS BEEN ORDERED AND PAIN CREAM HAS BEEN PRESCRIBED. FOLLOW UP INFO IDENTIFIED THE PAIN CREAM DID NOT RELIEVE THE PAIN AND THE PT IS STILL EXPERIENCING PAIN AT THE PADDLE LEAD SITE. THE CT SCAN IS PENDING SCHEDULING. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    DEVICE #1 OF 2: REFERENCE MFR. REPORT: 1627487-2014-26545.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290601 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 4381986

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other IMPLANTED: