BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCS RECHARGEABLE IPG

    MDR report key: 21238236 · Received January 26, 2025

    Report

    Report Number
    1627487-2025-00398
    Event Type
    Injury
    Date Received
    January 26, 2025
    Date of Event
    October 8, 2024
    Report Date
    March 24, 2025
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    UDI-DI
    05415067017093
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE IS ESTIMATED. D6A: IMPLANT DATE IS UNKNOWN. DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE DEVICE INFORMATION. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Additional Manufacturer Narrative · 0

    CORRECTION SECTION D: DEVICE INFORMATION HAS BEEN UPDATED. CORRECTION: MANUFACTURING SITE IN D3 SHOULD HAVE BEEN ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) AND MFR NUMBER 1 SHOULD HAVE BEEN 3006705815. CORRECTION: A1: PATIENT INITIALS CORRECTED TO (B)(6).

    Additional Manufacturer Narrative · 0

    A REVIEW OF DOCUMENTATION SUPPLIED WITH THE IMPLANT STATES THAT THE IMPLANT MUST BE CHARGED EVERY 30 TO 90 DAYS TO AVOID BATTERY DEPLETION. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT IS CONSISTENT WITH USER ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT DID NOT RECHARGE THE IPG AS RECOMMENDED. AS SUCH, THE IPG BECAME INOPERABLE. IN TURN, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770635 SCS RECHARGEABLE IPG SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3772 A000119503 05415067017093

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SCS LEAD (X2)