BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 8728166 · Received June 24, 2019

    Report

    Report Number
    3006630150-2019-02999
    Event Type
    Injury
    Date Received
    June 24, 2019
    Date of Event
    May 30, 2019
    Report Date
    August 5, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT DEVICES: REFERENCE NUMBER: 11091369, PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2316500, MODEL: SC-2316-50, SERIAL: (B)(4), BATCH: 5009092. REFERENCE NUMBER: 11098251, PRODUCT FAMILY: SCS-SPLITTERS, UPN: M365SC3400300, MODEL: SC-3400-30, SERIAL: (B)(4), BATCH: 2000019035. REFERENCE NUMBER: 11098268, PRODUCT FAMILY: SCS-SPLITTERS, UPN: M365SC3400300, MODEL: SC-3400-30, SERIAL: (B)(4), BATCH: 2000019035. REFERENCE NUMBER: 11098312, PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: M365SC43160, MODEL: SC-4316, SERIAL: NULL, BATCH: 21851808. REFERENCE NUMBER: 11091314, PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2316500, MODEL: SC-2316-50, SERIAL: (B)(4), BATCH: 5010849. THE RETURNED SC-1132 IPG PASSED THE FUNCTIONAL TEST AND REVEALED NO ANOMALIES. VISUAL INSPECTION OF THE TWO RETURNED SC-3400-30 LEAD SPLITTERS FOUND NO ANOMALIES. IT IS INDICATED THAT THE TWO LEADS AND CLIK ANCHORS WILL NOT BE RETURNED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS AND CLIK ANCHORS 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 WAS EXPERIENCING LITTLE PAIN RELIEF AND UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POST OPERATIVELY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT DEVICES: REFERENCE NUMBER: (B)(4), PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2316-50, SERIAL: (B)(4), BATCH: (B)(4). REFERENCE NUMBER: (B)(4), PRODUCT FAMILY: SCS-SPLITTERS, UPN: (B)(4), MODEL: SC-3400-30, SERIAL: (B)(4), BATCH: 2000019035. REFERENCE NUMBER: (B)(4), PRODUCT FAMILY: SCS-SPLITTERS, UPN: (B)(4), MODEL: SC-3400-30, SERIAL: (B)(4), BATCH: 2000019035. REFERENCE NUMBER: (B)(4), PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: (B)(4), MODEL: SC-4316, SERIAL: NULL, BATCH: 21851808. REFERENCE NUMBER: (B)(4), PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2316-50, SERIAL: (B)(4), BATCH: (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING LITTLE PAIN RELIEF AND UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520194 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 2000023007 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention