BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR

    MDR report key: 17218162 · Received June 28, 2023

    Report

    Report Number
    3006705815-2023-03986
    Event Type
    Injury
    Date Received
    June 28, 2023
    Date of Event
    February 24, 2023
    Report Date
    June 28, 2023
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    UDI-DI
    05415067031419
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT #1 PI MAIN [PI-2023-0040874-01]. A PATIENT EXPERIENCED PAIN AT THE IPG SITE AND INEFFECTIVE STIMULATION WAS REPORTED TO ABBOTT. THE PATIENT WAS REPROGRAMMED TO ADDRESS INEFFECTIVE STIMULATION, AND NO INTERVENTION FOR PAIN AT THE IPG SITE. 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. DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE PATIENT INFORMATION. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED. DATE OF EVENT IS ESTIMATED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IPG KEPT FLIPPING IN THE POCKET, THIS CAUSED THE PATIENT TO EXPERIENCE PAIN AT THE IPG SITE. SURGICAL INTERVENTION TOOK PLACE WHERE THE PATIENTS IPG WAS REPOSITIONED WITHIN THE POCKET. RELATED MANUFACTURER REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1542835 PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3660 A000131082 05415067031419

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Unknown Other