BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL EXTENSION

    MDR report key: 2042053 · Received March 31, 2011

    Report

    Report Number
    1627487-2011-01337
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 4 OF 4. REFERENCE MANUFACTURER REPORTS: 1627487-2011-01334, 1627487-2011-01335 AND 1627487-2011-01336. THE PATIENT RECEIVED HIS SCS SYSTEM, INCLUDING AN IPG (IMPLANTED ON (B)(6) 2006), FOUR LEADS (FROM THE SAME LOT), AND TWO EXTENSIONS (FROM TWO SEPARATE LOTS), ON (B)(6) 2007. THE PATIENT'S LEADS WERE IMPLANTED OCCIPITALLY (OFF-LABEL). IT WAS REPORTED THAT THE PATIENT LOST THERAPY. IT WAS REPORTED THAT ONE OF THE LEADS EXHIBITED HIGH IMPEDANCE VALUES AND ANOTHER LEAD HAD MIGRATED. THE PHYSICIAN EXPLANTED AND REPLACED ALL FOUR LEADS AND BOTH EXTENSIONS ON (B)(6) 2011. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE EXTERNAL CHARGING COIL ON THE IPG HAD A CUT IN IT; THEREFORE, THE IPG WAS ALSO EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL EXTENSION SPINAL CORD STIMULATION EXTENSION LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3341 69549

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention