BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 8551879 · Received April 25, 2019

    Report

    Report Number
    3006630150-2019-01889
    Event Type
    Injury
    Date Received
    April 25, 2019
    Date of Event
    April 1, 2019
    Report Date
    June 10, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD A LOT OF SCAR TISSUE, THE PHYSICIAN HAD TO CUT THE LEADS TO EXPLANT THE DEVICES, AND THEY WERE SUBSEQUENTLY DISCARDED. IPG SC-1132, 150677: THE RETURNED DEVICE WAS ANALYZED, AND NO ANOMALIES WERE FOUND. LEADS SC-2366-50, 3101737 AND 3101736: THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT REQUESTED A REMOVAL OF THE NEUROSTIMULATOR SYSTEM. THE PATIENT INDICATED THAT HE DID INITIALLY BENEFIT FROM THE THERAPY, HOWEVER WAS NOW RECEIVING INEFFECTIVE PAIN THERAPY. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICES COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4), MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 19660475. PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4), MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 19660475.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT REQUESTED A REMOVAL OF THE NEUROSTIMULATOR SYSTEM. THE PATIENT INDICATED THAT HE DID INITIALLY BENEFIT FROM THE THERAPY, HOWEVER WAS NOW RECEIVING INEFFECTIVE PAIN THERAPY. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342896 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 19556941 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention