BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2092657 · Received May 10, 2011

    Report

    Report Number
    1627487-2011-01495
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    March 21, 2011
    Report Date
    April 11, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 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

    DEVICE 1 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-01496. THE PT RECEIVED HER SCS SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS, ON (B)(6) 2010. THE LEADS WERE PLACED AT THE T8 LEVEL. IT WAS REPORTED THAT THE PT LOST STIMULATION AFTER SHE HAD A CERVICAL AND DEEP TISSUE MASSAGE. SHE STATED THAT THE MASSAGE DID NOT GO BELOW THE SHOULDER BLADES. REPROGRAMMING EFFORTS WERE UNSUCCESSFUL AT RESOLVING THE ISSUE. IT WAS REPORTED THAT THE LEADS HAD MIGRATED SUPERIORLY. THE PHYSICIAN PLANS TO PERFORM A REVISION PROCEDURE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3062358

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention