BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 4092004 · Received August 27, 2014

    Report

    Report Number
    1627487-2014-21571
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 6, 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 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

    IT WAS REPORTED THE PATIENT EXPERIENCED A PINCHING SENSATION ON THE SIDE OF THE NECK, AND THE LEADS APPEARED SUPERFICIAL. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2014 TO REPOSITION THE LEAD AWAY FROM THE NERVE ROOT AND BURY THE LEADS DEEPER. THE PATIENT REPORTED FEELING 'COMFORTABLE' POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518763 PENTA SCS LEAD GZB ST. JUDE MEDICAL, NEUROMODULATION 3228 4373028

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other SCS EXTENSION, MODEL: 3383 (2)| SCS IPG, MODEL: 3788| IMPLANT DATE:| IMPLANT DATE: