BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 9507933 · Received December 20, 2019

    Report

    Report Number
    3006630150-2019-07568
    Event Type
    Injury
    Date Received
    December 20, 2019
    Date of Event
    August 19, 2019
    Report Date
    December 20, 2019
    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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-1160. SERIAL NUMBER: (B)(4). BATCH/LOT NUMBER: 353401. MODEL/CATALOG DESCRIPTION: SPECTRA WAVEWRITER IPG KIT. MODEL NUMBER/CATALOG NUMBER: SC-2317-50. SERIAL NUMBER: (B)(4). BATCH/LOT NUMBER: 5143615. MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG AND LEADS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT GETTING ANY STIMULATION EVEN WHEN THE SCS DEVICE WAS FULLY MAXED OUT AND WAS ALSO EXPERIENCING DISCOMFORT AT THE POCKET SITE. HIGH IMPEDANCES WERE NOTED ON EACH LEAD. IT WAS CONFIRMED VIA X-RAY THAT BOTH LEADS PULLED COMPLETELY OUT AND WERE WRAPPED AROUND THE IPG. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS AND IPG WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296570 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 5143307 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention