BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 1936271 · Received December 14, 2010

    Report

    Report Number
    1627487-2010-03918
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    SJM NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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 3. SEE MFR REPORT # 1627487-2010-03919. SEE MFR REPORT # 1627487-2010-03934. THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2008. IT WAS REPORTED THAT THE PT WAS EXPERIENCING DISCOMFORT DURING STIMULATION AS WELL AS HEATING AT THE IPG POCKET SITE. AN X-RAY SHOWED THAT ONE OF THE LEADS HAD MIGRATED. THE PT WAS REPROGRAMMED BUT THE ISSUE WAS NOT RESOLVED. NO FURTHER INFORMATION IS KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD KIT, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW SJM NEUROMODULATION DIV. 3186 172588

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention