BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2992469 · Received March 4, 2013

    Report

    Report Number
    1627487-2013-06019
    Event Type
    Injury
    Date Received
    March 4, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 10, 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 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 THAT DURING THE POST-OPERATIVE TESTING OF THE SYSTEM THE PT DID NOT HAVE ADEQUATE COVERAGE. A CT SCAN INDICATED THE LEAD HAD MIGRATED POST-OP. FOLLOW-UP IDENTIFIED THE PHYSICIAN REPOSITIONED THE PADDLE LEAD ON (B)(6) 2013. TESTING WAS DONE IN THE RECOVERY AREA AND THE PT STATED THAT STIMULATION WAS COVERING THE PAIN AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91580 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3845115

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788