BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 10621772 · Received October 2, 2020

    Report

    Report Number
    1627487-2020-32066
    Event Type
    Injury
    Date Received
    October 2, 2020
    Date of Event
    August 31, 2020
    Report Date
    May 28, 2021
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734401913
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION INDICATES SURGICAL INTERVENTION WAS UNDERTAKEN ON 5 MARCH 2021 WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED. ISSUE RESOLVED.

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT IS ESTIMATED. THE RESULTS, METHOD AND CONCLUSION CODES ALONG WITH THE INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNCOMFORTABLE STIMULATION. THE PATIENT FELT A ZAPPING SENSATION IN HER LEGS. THE PATIENT STATED THEY FELL OFF THEIR BIKE A FEW MONTHS PRIOR AND ANOTHER FALL APPROXIMATELY A YEAR AGO. THE PATIENT MAY UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1085844 PENTA 3MM LEAD, 60 CM SCS PADDLE LEAD LGW ABBOTT MEDICAL 3228 3456416 05414734401913

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other