BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 16644827 · Received March 30, 2023

    Report

    Report Number
    3006705815-2023-01904
    Event Type
    Injury
    Date Received
    March 30, 2023
    Date of Event
    March 6, 2023
    Report Date
    April 21, 2023
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    UDI-DI
    05415067017246
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    (B)(4). REPORT SOURCE, FOREIGN: UK. THE PRODUCT HAS NOT BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AT THIS TIME. ATTEMPTS TO RETRIEVE THE DEVICE ARE UNDERWAY BUT TO DATE NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ADDITIONAL ASSOCIATED PRODUCTS: KNE-UNK-LPS FLEX FEMORAL SIZE E; KNE-UNK-LPS FLEX INSERT.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2023-01903. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO LEAD MIGRATIONS. SURGICAL INTERVENTION OCCURRED ON (B)(6) 2023 DURING WHICH THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172754 OCTRODE LEAD KIT, 60CM LENGTH PERCUTANEOUS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3186 A000124237 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other SCS IPG.