BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 7705408 · Received July 19, 2018

    Report

    Report Number
    3006630150-2018-60262
    Event Type
    Injury
    Date Received
    July 19, 2018
    Date of Event
    June 20, 2018
    Report Date
    September 21, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2316-50E; SERIAL NUMBER: (B)(4); BATCH/LOT NUMBER: 5062435; MODEL/CATALOG DESCRIPTION: INFINION 16 TRIAL LEAD KIT 50 CM. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES 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 MED WATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2316-50E; SERIAL NUMBER: (B)(4); BATCH/LOT NUMBER: 5062435; MODEL/CATALOG DESCRIPTION: INFINION 16 TRIAL LEAD KIT 50 CM. ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER INFORMATION COULD BE OBTAINED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE DEVICES WERE FOUND TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A TRIAL PROCEDURE, THE PATIENT WAS CONFUSED AND HAD A FEVER. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND HAD AN EARLY LEAD PULL AS INFECTION WAS SUSPECTED. IT WAS NOTED THAT THE INFECTION WAS NOT PROCEDURE RELATED AND THE CAUSE WAS UNKNOWN. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND WAS REPORTEDLY DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A TRIAL PROCEDURE, THE PATIENT WAS CONFUSED AND HAD A FEVER. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND HAD AN EARLY LEAD PULL AS INFECTION WAS SUSPECTED. IT WAS NOTED THAT THE INFECTION WAS NOT PROCEDURE RELATED AND THE CAUSE WAS UNKNOWN. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND WAS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544974 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 5062430 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention