BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION 16

    MDR report key: 8171950 · Received December 17, 2018

    Report

    Report Number
    3006630150-2018-62322
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    December 3, 2018
    Report Date
    January 7, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE REMAINING CONTACTS WERE REMOVED FROM THE PATIENTS BODY DURING THE IMPLANT PROCEDURE. PATIENT WAS DOING WELL POSTOPERATIVELY. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT DURING A LEAD PULL, THREE CONTACTS WERE LEFT ON THE PATIENTS BODY.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2316-50E, SERIAL NUMBER : (B)(4), BATCH/LOT NUMBER: 5100766, MODEL/CATALOG DESCRIPTION: INFINION 16 TRIAL LEAD KIT 50 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD PULL, THREE CONTACTS WERE LEFT ON THE PATIENTS BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010244 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 5084073 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention