BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION NOVI

    MDR report key: 8968358 · Received September 6, 2019

    Report

    Report Number
    3006630150-2019-04869
    Event Type
    Injury
    Date Received
    September 6, 2019
    Date of Event
    August 16, 2019
    Report Date
    September 30, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729897835
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE INCISION SITES. SYMPTOMS OF REDNESS AND DISCOMFORT WERE NOTED. THE PHYSICIAN BELIEVED THAT INFECTION WAS NOT DEVICE OR PROCEDURE RELATED. THE PATIENT WAS PLACED ON ANTIBIOTICS. THE PATIENT WAS REPORTEDLY DOING WELL AND INCISIONS SEEM TO BE IMPROVING.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-3138-35, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 1074520/1076179/7038566/7038963, MODEL/CATALOG DESCRIPTION: LEAD EXTENSION KIT 35CM. MODEL NUMBER/CATALOG NUMBER: SC-8336-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7031260, MODEL/CATALOG : COVEREDGE 32 SURGICAL LEAD KIT 50 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE INCISION SITES. SYMPTOMS OF REDNESS AND DISCOMFORT WERE NOTED. THE PHYSICIAN BELIEVED THAT INFECTION WAS NOT DEVICE OR PROCEDURE RELATED. THE PATIENT WAS PLACED ON ANTIBIOTICS. THE PATIENT WAS REPORTEDLY DOING WELL AND INCISIONS SEEM TO BE IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762649 PRECISION NOVI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1140 201626 08714729897835

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention