BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 13747225 · Received March 12, 2022

    Report

    Report Number
    3006630150-2022-00990
    Event Type
    Injury
    Date Received
    March 12, 2022
    Date of Event
    January 21, 2022
    Report Date
    May 13, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: EXACT DATE UNKNOWN. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 5173840. PRODUCT FAMILY: SCS-EXTENSION: UPN: M365SC3138550, MODEL: SC-3138-55, SERIAL: (B)(4), BATCH: 7062855. PRODUCT FAMILY: SCS-EXTENSION: UPN: M365SC3138550, MODEL: SC-3138-55, SERIAL: (B)(4), BATCH: 7062966. PRODUCT FAMILY: SCS-EXTENSION: UPN: M365SC3138550, MODEL: SC-3138-55, SERIAL: (B)(4), BATCH: 5152066. PRODUCT FAMILY: SCS-EXTENSION: UPN: M365SC3138550, MODEL: SC-3138-55, SERIAL: (B)(4), BATCH: 7041407.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PHYSICIAN ASSESSED THE LEADS HAD HIGH IMPEDANCES. ATTEMPTS TO REPROGRAM THE DEVICE WERE UNSUCCESSFUL AND THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEADS WERE REPLACED AND THE LEAD EXTENSIONS WERE REMOVED. AT THAT TIME, THE PHYSICIAN HAD RELOCATED THE IMPLANTABLE PULSE GENERATOR (IPG) FROM THE ANTERIOR RIGHT SIDE TO THE UPPER RIGHT BUTTOCK TO ACCOMMODATE THE REMOVAL OF THE LEAD EXTENSIONS. THE PATIENT DID WELL POST-OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PHYSICIAN ASSESSED THE LEADS HAD HIGH IMPEDANCES. ATTEMPTS TO REPROGRAM THE DEVICE WERE UNSUCCESSFUL AND THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEADS WERE REPLACED AND THE LEAD EXTENSIONS WERE REMOVED. AT THAT TIME, THE PHYSICIAN HAD RELOCATED THE IMPLANTABLE PULSE GENERATOR (IPG) FROM THE ANTERIOR RIGHT SIDE TO THE UPPER RIGHT BUTTOCK TO ACCOMMODATE THE REMOVAL OF THE LEAD EXTENSIONS. THE PATIENT DID WELL POST-OPERATIVELY. THIS IS A DUPLICATE REPORT. PLEASE REFER TO MFR NUMBER 3006630150-2022-00548 FOR FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2071949 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 5172335 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention