BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 9993574 · Received April 23, 2020

    Report

    Report Number
    3006630150-2020-01882
    Event Type
    Injury
    Date Received
    April 23, 2020
    Date of Event
    March 29, 2020
    Report Date
    November 4, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797821
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT:-INSERTION NEEDLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: INSERTION NEEDLE. PRODUCT FAMILY: SCS-SURG ACC, UPN: M365SC42000, MODEL: SC-4200, SERIAL: N/A, LOT: N/I. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2316700, MODEL: SC-2316-70, SERIAL: (B)(6), LOT: 7071404.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: INSERTION NEEDLE: PRODUCT FAMILY: N/I; UPN: N/I; MODEL: N/I; SERIAL/LOT: N/I.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AFTER COMPLETING THE TEMPORARY TRIAL LEAD PROCEDURE AND PRIOR TO THE PERMANENT IMPLANT PROCEDURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT AN EPIDURAL ABSCESS DECOMPRESSION PROCEDURE. THE EVENT WAS ASSESSED TO BE RELATED TO THE PROCEDURE AND POSSIBLY RELATED TO THE DEVICE HARDWARE. INFORMATION REGARDING THE DEVICE MODEL, SERIAL NUMBER, IMPLANT AND EXPLANT DATE, HAS NOT BEEN PROVIDED DESPITE MULTIPLE ATTEMPTS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT MAY POSSIBLY BE DUE TO THE LEAD AND INSERTION NEEDLE. THE EVENT HAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AFTER COMPLETING THE TEMPORARY TRIAL LEAD PROCEDURE AND PRIOR TO THE PERMANENT IMPLANT PROCEDURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT AN EPIDURAL ABSCESS DECOMPRESSION PROCEDURE. THE EVENT WAS ASSESSED TO BE RELATED TO THE PROCEDURE AND POSSIBLY RELATED TO THE DEVICE HARDWARE. INFORMATION REGARDING THE DEVICE MODEL, SERIAL NUMBER, IMPLANT AND EXPLANT DATE, HAS NOT BEEN PROVIDED DESPITE MULTIPLE ATTEMPTS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT MAY POSSIBLY BE DUE TO THE LEAD AND INSERTION NEEDLE. THE EVENT HAS RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED A PROGRESSIVE INCREASE IN LUMBAR PAIN TWO DAYS AFTER THE TRIAL PROCEDURE. MAGNETIC RESONANCE IMAGING REVEALED A SIGNIFICANT COLLECTION PRESUMED TO BE INFECTIVE BETWEEN T12/L1. THE PATIENT UNDERWENT A T11- L1 LAMINECTOMY AND DRAINAGE OF THE EPIDURAL ABSCESS WITH NO COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AFTER COMPLETING THE TEMPORARY TRIAL LEAD PROCEDURE AND PRIOR TO THE PERMANENT IMPLANT PROCEDURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT AN EPIDURAL ABSCESS DECOMPRESSION PROCEDURE. THE EVENT WAS ASSESSED TO BE RELATED TO THE PROCEDURE AND POSSIBLY RELATED TO THE DEVICE HARDWARE. INFORMATION REGARDING THE DEVICE MODEL, SERIAL NUMBER, IMPLANT AND EXPLANT DATE, HAS NOT BEEN PROVIDED DESPITE MULTIPLE ATTEMPTS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT MAY POSSIBLY BE DUE TO THE LEAD AND INSERTION NEEDLE. THE EVENT HAS RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED A PROGRESSIVE INCREASE IN LUMBAR PAIN TWO DAYS AFTER THE TRIAL PROCEDURE. MAGNETIC RESONANCE IMAGING REVEALED A SIGNIFICANT COLLECTION PRESUMED TO BE INFECTIVE BETWEEN T12/L1. THE PATIENT UNDERWENT A T11- L1 LAMINECTOMY AND DRAINAGE OF THE EPIDURAL ABSCESS WITH NO COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AFTER COMPLETING THE TEMPORARY TRIAL LEAD PROCEDURE AND PRIOR TO THE PERMANENT IMPLANT PROCEDURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT AN EPIDURAL ABSCESS DECOMPRESSION PROCEDURE. THE EVENT WAS ASSESSED TO BE RELATED TO THE PROCEDURE AND POSSIBLY RELATED TO THE DEVICE HARDWARE. INFORMATION REGARDING THE DEVICE MODEL, SERIAL NUMBER, IMPLANT AND EXPLANT DATE HAS NOT BEEN PROVIDED DESPITE MULTIPLE ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455564 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-70 7071217 08714729797821

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Hospitalization| R