BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 15514389 · Received September 30, 2022

    Report

    Report Number
    1627487-2022-05351
    Event Type
    Injury
    Date Received
    September 30, 2022
    Date of Event
    September 9, 2022
    Report Date
    November 23, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734401913
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE PATIENT INFORMATION. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY. PATIENT REQUESTED TO HAVE THE SYSTEM REMOVED TO BE ABLE TO HAVE MRI. SURGICAL INTERVENTION MAY BE TAKEN TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY. PATIENT REQUESTED TO HAVE THE SYSTEM REMOVED TO BE ABLE TO HAVE MRI. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2022, WHERE THE ENTIRE SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1827475 PENTA 3MM LEAD, 60 CM SCS PADDLE LEAD LGW ABBOTT MEDICAL 3228 4552168 05414734401913

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other SCS IPG