BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA SURGICAL LEAD

    MDR report key: 2030884 · Received March 22, 2011

    Report

    Report Number
    1627487-2011-01292
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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

    THE PT REC'D HIS SCS SYSTEM, INCLUDING AN IPG AND SURGICAL LEAD, ON (B)(6) 2010 FOR LOW BACK AND BILATERAL LEG PAIN. ON (B)(6) 2011, THE PT REPORTED THAT HE HAD FALLEN IN THE SHOWER AND INJURED HIS FOOT AND KNEE. APPROX ONE WEEK AFTER THE FALL, HE STATED THAT HE FELT OVERSTIMULATION. THE PT ALLEGEDLY DECLINED MEETING FOR A REPROGRAMMING SESSION. THE PT STATED THAT HIS ORTHOPEDIC SURGEON WOULD LIKE TO PERFORM AN MRI OF HIS FOOT AND KNEE SO WE WILL NEED TO HAVE HIS SYSTEM EXPLANTED. THE PT WILL MEET WITH HIS PHYSICIAN TO DISCUSS A POTENTIAL EXPLANT PROCEDURE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    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 2875822

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3716