BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA SURGICAL LEAD

    MDR report key: 2023569 · Received March 16, 2011

    Report

    Report Number
    1627487-2011-01256
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 2 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-01255. THE PATIENT RECEIVED HIS SCS SYSTEM, INCLUDING AN IPG AND SURGICAL LEAD, ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG POCKET SITE UP TO THE LEAD SITE. THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE IPG WITH A SMALLER MODEL ON (B)(6) 2011. DURING THE SAME PROCEDURE, THE LEAD WAS REVISED. THE PHYSICIAN THOUGHT THAT THE LEAD WAS ORIGINALLY TUNNELED IN THE INCORRECT TISSUE PLANE; THEREFORE HE TUNNELED THE PATIENT'S LEAD INTO DEEPER TISSUE. FOLLOW UP ON THE PATIENT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3228 3252467

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention