BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 18833160 · Received March 4, 2024

    Report

    Report Number
    3006630150-2024-01178
    Event Type
    Injury
    Date Received
    March 4, 2024
    Date of Event
    August 28, 2023
    Report Date
    July 23, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED A MONTH AGO FROM DATE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 7082400. PRODUCT FAMILY: SCS-IPG-PC. UPN: M365SC14160. MODEL: SC-1416. SERIAL: (B)(6). BATCH: 207408.

    Additional Manufacturer Narrative · 0

    (B)(6). THE IPG WAS RETURNED FOR ANALYSIS. COMMUNICATION COULD NOT BE ESTABLISHED WITH A KNOWN GOOD REMOTE CONTROL (RC) OR CLINICIAN PROGRAMMER (CP). THE IPG WAS THEN CUT OPEN, AND INTERNAL ELECTRICAL MEASUREMENTS REVEALED EXCESSIVE SLEEP CURRENT AND LOW RESISTANCE OF A NODE WHERE HIGH RESISTANCE WAS EXPECTED, WHICH CONFIRMS THAT THE APPLICATION-SPECIFIC INTEGRATED CIRCUIT (ASIC) CHIP IS DAMAGED. THIS DAMAGE IS TYPICALLY CAUSED BY THE IPG EXPOSURE TO ELECTROCAUTERY. IN ADDITION, THE DATA LOGS WERE ABLE TO BE RETRIEVED AND THEY REVEALED NO EVIDENCE OF ANY ANOMALIES RELATED TO BATTERY DEPLETION, OR USAGE. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES UNABLE TO CONFIRM THE AS REPORTED ALLEGATION OF THE PATIENT WAS EXPERIENCING NON-TARGET STIMULATION DUE TO LEAD MIGRATION WITH TESTING OF THE RETURNED PRODUCT. HOWEVER, A LABELING REVIEW REVEALED THAT THE REPORTED EVENT OF MIGRATION IS A KNOWN RISK ASSOCIATED WITH THE USE OF AN IMPLANTABLE PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION. THEREFORE, THIS INVESTIGATION IS ASSIGNED A PROBABLE CAUSE OF KNOWN INHERENT RISK OF DEVICE. IN ADDITION, DESPITE MULTIPLE ATTEMPTS THE IPG COULD NOT COMMUNICATE. THE IPG WAS RECEIVED IN A NON-FUNCTIONAL STATE DUE TO ELECTROCAUTERY DAMAGED. THEREFORE, THE PROBABLE CAUSE SELECTED FOR THIS EVENT IS UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING NON-TARGET STIMULATION. IMAGING SHOWED THAT THE LEADS HAD MIGRATED SIGNIFICANTLY. IT WAS ALSO NOTED THAT THE PATIENT HAD AN ISSUE WITH THE SIZE OF BATTERY AND WHERE IT WAS LOCATED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE. DURING THE SURGERY WHEREIN AN ELECTROCAUTERY WAS USED, THE REMOTE CONTROL KEPT SAYING COMMUNICATION ERROR. THE PHYSICIAN OPTED TO REPLACE THE IPG. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE DISCARDED BY THE FACILITY. PER THE PHYSICIANS IMPLANT MANUAL, ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND WARNS AGAINST THE USE OF ELECTROCAUTERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING NON-TARGET STIMULATION. IMAGING SHOWED THAT THE LEADS HAD MIGRATED SIGNIFICANTLY. IT WAS ALSO NOTED THAT THE PATIENT ALSO HAD AN ISSUE WITH THE SIZE OF BATTERY AND WHERE IT WAS LOCATED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE. DURING THE SURGERY WHEREIN AN ELECTROCAUTERY WAS USED, THE REMOTE CONTROL KEPT SAYING COMMUNICATION ERROR. THE PHYSICIAN OPTED TO REPLACE THE IPG. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE DISCARDED BY THE FACILITY. PER THE PHYSICIANS IMPLANT MANUAL, ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND WARNS AGAINST THE USE OF ELECTROCAUTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519476 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7082357 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention