BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 10995956 · Received December 12, 2020

    Report

    Report Number
    3006630150-2020-06169
    Event Type
    Injury
    Date Received
    December 12, 2020
    Date of Event
    November 18, 2020
    Report Date
    April 22, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2316700, MODEL: SC-2316-70, SERIAL: (B)(6), BATCH: 17925201. PRODUCT FAMILY: SCS-SPLITTERS UPN: M365SC3400300, MODEL: SC-3400-30, SERIAL: (B)(6), BATCH: 18117905. THE RETURNED IPG SC-1132(134084) WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. EXTERNAL VISUAL INSPECTION OF SC-2158-50 (3000597 AND 3000604) AND SC-3400-30 (662404) FOUND NO ANOMALIES. ANALYSIS OF SC-2316-70 (3004874) REVEALED THAT THE LEAD EXHIBITED 12 CABLE FRACTURES IN MULTIPLE PLACES, AT THE CLICK SITE, AND IN THE PROXIMAL ARRAY. SINCE THERE WAS NO REPORT ABOUT IMPEDANCE ANOMALIES, THOSE FRACTURES MOST LIKELY WERE INTRODUCED DURING THE EXPLANT PROCEDURE AS BEING PULLED OUT DURING THE PROCEDURE. PRODUCT LABELING REVIEWS IDENTIFIED THAT THE DEVICES WERE USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. PERSISTENT PAIN AT THE IPG OR LEAD SITE ARE NOTED WITHIN THE DFUS AS POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF THE DEVICES THE INVESTIGATION CONCLUDED THAT THE REPORTED EVENT WAS NOT CONFIRMED THROUGH DEVICE ANALYSIS. NO PROBLEM HAS BEEN DETECTED WITH IPG SC-1132(134084), LEADS SC-2158-50 (3000597 AND 3000604) OR LEAD SPLITTER SC-3400-30 (662404). THE PROBABLE CAUSE OF THE CABLE FRACTURES ON LEAD SC-2316-70 (3004874) ARE MOST LIKELY DUE TO THE EXPLANT PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE AND WAS NO LONGER USING THE SCS SYSTEM. THE PHYSICIAN EXPLANTED THE SCS SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE AND WAS NO LONGER USING THE SCS SYSTEM. THE PHYSICIAN EXPLANTED THE SCS SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE AND WAS NO LONGER USING THE SCS SYSTEM. THE PHYSICIAN EXPLANTED THE SCS SYSTEM.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4), MODEL: SC-2158-50, SERIAL: (B)(4), BATCH: 17856378. PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4), MODEL: SC-2158-50, SERIAL: (B)(4), BATCH: 17856378.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE AND WAS NO LONGER USING THE SCS SYSTEM. THE PHYSICIAN EXPLANTED THE SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461545 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 18266093 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention