BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 15397112 · Received September 9, 2022

    Report

    Report Number
    1627487-2022-05001
    Event Type
    Injury
    Date Received
    September 9, 2022
    Date of Event
    August 17, 2022
    Report Date
    October 28, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067017246
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    CORRECTION: SECTION D1 - BRAND NAME SHOULD HAVE BEEN OCTRODE LEAD KIT, 60CM LENGTH RATHER THAN EPIDURAL NEEDLE, 14 GAUGE, 6" (15CM). CORRECTION: SECTION D2 - TYPE OF DEVICE - COMMON DEVICE NAME SHOULD HAVE BEEN PERCUTANEOUS LEAD RATHER THAN ACCESSORY. CORRECTION: SECTION D2 - DEVICE PRODUCT CODE (FDA PRODUCT CODE CLASSIFICATION) SHOULD HAVE BEEN LGW RATHER THAN GZB. CORRECTION: SECTION D4 - ADDITIONAL DEVICE INFORMATION -THE UDI (B)(4) SHOULD HAVE BEEN (B)(4) RATHER THAN (B)(4). CORRECTION: SECTION D4 - ADDITIONAL DEVICE INFORMATION - THE MODEL NUMBER SHOULD HAVE BEEN 3186 RATHER THAN 1116. CORRECTION: SECTION G3 - THE PMA/510(K) # NUMBER SHOULD HAVE BEEN P010032 RATHER THAN K110609.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER 3006705815-2022-15982 AND 3006705815-2022-15983. IT WAS REPORTED THAT DURING PATIENT'S LEAD REVISION PROCEDURE ON (B)(6) 2022 (SEE RELATED MANUFACTURER REFERENCE NUMBER 3006705815-2022-15982 AND 3006705815-2022-15983) PATIENT EXPERIENCED A CEREBROSPINAL (CSF) LEAK AFTER THE PHYSICIAN GAINED ACCESS TO THE EPIDURAL SPACE. PATIENT REPORTED HAVING A HEADACHE AND WAS ADVISED TO GO ON BED REST AND DRINK HIGHLY CAFFEINATED DRINKS. FOLLOW-UP INDICATED THAT THE PATIENT'S HEADACHE HAS SINCE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806777 OCTRODE LEAD KIT, 60CM LENGTH PERCUTANEOUS LEAD LGW ABBOTT MEDICAL 3186 A000126971 05415067017246
    2881044 OCTRODE LEAD KIT, 60CM LENGTH PERCUTANEOUS LEAD LGW ABBOTT MEDICAL 3186 A000126971 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other SCS ANCHOR (2)| SCS IPG (1)| SCS LEAD (2)