BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 21610206 · Received March 14, 2025

    Report

    Report Number
    1627487-2025-01262
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    November 25, 2024
    Report Date
    March 14, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067017253
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    LEAD AND ELECTIVE IPG REPLACEMENT. (B)(6) 2025, (B)(6) EMAILED NMD COMPLAINTS REPORTING ON (B)(6) 2025 PATIENT HAD A FULL SYSTEM REVISION TODAY. EVERYTHING HE HAD WAS REMOVED AND REPLACED. PADDLE HAD MIGRATED AND WE DID AN ELECTIVE IPG REPLACEMENT AT THE SAME TIME. THERAPY RESTORED. NO ISSUES. 260 LBS. PS DATE: (B)(6) 2025. PPG COMPLAINT HISTORY REVIEW: (B)(6) 2025 (B)(6): COMPLAINT HISTORY SEARCH FOR THE LAST 4 YEARS FOUND PRIOR REPORT(S) ON THIS PATIENT: NONE. IT WAS REPORTED PATIENT' LEAD HAD MIGRATED. TO ADDRESS THE ISSUE, PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED. THERAPY WAS RESTORED POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900253 PENTA 3MM LEAD, 60 CM SCS LEAD LGW ABBOTT MEDICAL 3228 5920173 05415067017253

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Other SCS EXTENSION 2X| SCS IPG