BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA LEAD

    MDR report key: 2212573 · Received August 11, 2011

    Report

    Report Number
    1627487-2011-08035
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 14, 2011
    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 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 PATIENT RECEIVED SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT WAS GETTING RIB STIMULATION. X-RAY REVEALED THAT THE LEAD HAD MOVED TO THE LEFT. THE LEAD WAS REPOSITIONED ON (B)(6) 2011. AFTER THE REPOSITIONING, THE PATIENT REPORTED SHE WAS STILL IN PAIN AND FELT THE STIMULATION IN THE WRONG LOCATION. THE PHYSICIAN ADVISED THE PATIENT TO GIVE SOME HEALING TIME TO THE SURGERY LOCATION. THE DEVICE IS STILL IN USE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3315568

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention SCR IPG: MODEL 3788| SCS LEAD: MODEL 3228| IMPLANT DATE:| IMPLANT DATE: