BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2113486 · Received May 31, 2011

    Report

    Report Number
    1627487-2011-01582
    Event Type
    Injury
    Date Received
    May 31, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 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 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: 1627487-2011-01581. THE PATIENT RECEIVED HIS SCS SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS, ON (B)(6) 2009 FOR LOW BACK PAIN. IT WAS REPORTED THAT THE PATIENT FEELS OVERSTIMULATION IN THE RIBS ONLY WHEN STIMULATION IS INITIALLY TURNED ON. THE PATIENT REPORTED FEELING EFFECTIVE STIMULATION IN THE LOW BACK, AND THE AMPLITUDE CAN BE TURNED UP HIGH WITHOUT FEELING THE RIB OVERSTIMULATION. DIAGNOSTIC TESTS EXHIBITED LOW IMPEDANCE READINGS ON SEVERAL LEAD CONTACTS. FOLLOW UP ON THE PATIENT FOUND THAT X-RAYS REVEALED MIGRATION OF THE LEADS. THE PHYSICIAN PLANS TO PERFORM A LEAD REVISION PROCEDURE; HOWEVER, THE SURGERY DATE IS CURRENTLY UNDETERMINED. NO FURTHER INFORMATION 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 2850560

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3788