LINEAR ST
Report
- Report Number
- 3006630150-2023-03403
- Event Type
- Malfunction
- Date Received
- June 14, 2023
- Date of Event
- May 16, 2023
- Report Date
- July 31, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2023 ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218300, MODEL: SC-2218-30, SERIAL: (B)(6), BATCH: 17767347. A DATABASE ANALYSIS WAS PERFORMED ON THE IMPLANTABLE PULSE GENERATOR (IPG) WHICH REMAINS IMPLANTED AND WAS NOT RETURNED FOR ANALYSIS. THE DATABASE ANALYSIS RESULTS WERE INCONCLUSIVE DUE TO THE MISSING RECORDS IN THE PROVIDED DATABASE. HOWEVER, IT DID REVEAL HIGH IMPEDANCE READINGS ON CONTACTS 1-8 AND CONTACT 15 FROM THE CLINICIAN PROGRAMMER (CP) SESSIONS ON (B)(6) 2022 AND (B)(6) 2023. THE DATABASE WAS UNABLE TO CONFIRM THE SOURCE OF THE OBSERVED HIGH OHMS AND THE EXACT TIME WHEN THE IMPEDANCES WENT OUT OF RANGE. A REVIEW OF THE INSTRUCTIONS FOR USE (IFU) REVEALED THAT CHANGES IN TISSUE, POSITION OF THE ELECTRODES, LOOSE ELECTRICAL CONNECTIONS AND/OR LEAD FAILURE ARE ALL KNOWN RISKS WITH USE OF AN SCS SYSTEM.
CORRECTION TO BLOCK H6: PATIENT CODES. UPDATE TO BLOCK B5 AND BLOCK D6A. BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN MAY 2023. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218300. MODEL: SC-2218-30. SERIAL: (B)(6). BATCH: 17767347. A DATABASE ANALYSIS WAS PERFORMED ON THE IMPLANTABLE PULSE GENERATOR (IPG) WHICH REMAINS IMPLANTED AND WAS NOT RETURNED FOR ANALYSIS. THE DATABASE ANALYSIS RESULTS WERE INCONCLUSIVE DUE TO THE MISSING RECORDS IN THE PROVIDED DATABASE. HOWEVER, IT DID REVEAL HIGH IMPEDANCE READINGS ON CONTACTS 1-8 AND CONTACT 15 FROM THE CLINICIAN PROGRAMMER (CP) SESSIONS ON 19AUG2022 AND 02JUN2023. THE DATABASE WAS UNABLE TO CONFIRM THE SOURCE OF THE OBSERVED HIGH OHMS AND THE EXACT TIME WHEN THE IMPEDANCES WENT OUT OF RANGE. A REVIEW OF THE INSTRUCTIONS FOR USE (IFU) REVEALED THAT CHANGES IN TISSUE, POSITION OF THE ELECTRODES, LOOSE ELECTRICAL CONNECTIONS AND/OR LEAD FAILURE ARE ALL KNOWN RISKS WITH USE OF AN SCS SYSTEM.
DEVICE ANALYSIS WAS PERFORMED ON THE RETURNED LEAD EXTENSIONS, SC-3138-55 SERIAL NUMBERS (B)(6) , WHICH REVEALED THAT THE SEVENTH AND EIGHTH ELECTRODES OF THE DISTAL END ON EACH LEAD EXTENSION HAS A FRACTURED CABLE AT THE WELD NUGGET SITE. ENGINEERS DETERMINED THAT THIS TYPE OF DAMAGE TYPICALLY OCCURS WHEN EXCESSIVE TENSILE FORCE IS EXERTED ONTO THE LEAD BODY. ADDITIONALLY, THE FRACTURED CABLES WERE NOT EXPOSED AND ARE STILL CONTAINED WITHIN THE DISTAL ARRAY. A LABELING REVIEW WAS CONDUCTED WHICH DETERMINED THAT CHANGES IN TISSUE, LEAD MIGRATION, LEAD BREAKAGE, HARDWARE ISSUES, LOOSE CONNECTIONS OR ELECTRICAL ISSUES CAN RESULT IN INEFFECTIVE PAIN CONTROL AND ARE KNOWN RISKS OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION, AS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218300 MODEL: SC-2218-30 SERIAL: (B)(6) BATCH: 17767347. PRODUCT FAMILY: SCS-IPG-R UPN: M365SC1110020 MODEL: SC-1110-02 SERIAL: (B)(6) BATCH: 17349710. PRODUCT FAMILY: SCS-EXTENSION UPN: M365SC3138550 MODEL: SC-3138-55 SERIAL: (B)(6) BATCH: 17424659. PRODUCT FAMILY: SCS-EXTENSION UPN: M365SC3138550 MODEL: SC-3138-55 SERIAL: (B)(6) BATCH: 17424659.
UPDATES MADE TO BLOCK H11 AND BLOCK H6. DEVICE ANALYSIS PERFORMED ON THE RETURNED LEAD SC-2218-30 SERIAL (B)(6) REVEALED THAT ALL CABLES WERE COMPLETELY BROKEN AT THE BENT/KINKED LOCATION OF THE LEAD NEAR THE SETSCREW MARK OF THE CLIK ANCHOR. THERE WERE NO EXPOSED CABLES AT THE FRACTURE LOCATION. LABORATORY ANALYSIS DETERMINED THAT THE LEAD BECAME BENT/KINKED AFTER EXITING THE CLIK ANCHOR, EXPOSING THE BENT LOCATION TO EXCESSIVE MECHANICAL FORCE THAT CAUSED THE CABLES TO FRACTURE AT THE ANCHOR POINT. BASED ON ALL AVAILABLE INFORMATION, ENGINEERS CONCLUDED THAT THE HIGH IMPEDANCE MEASUREMENTS RESULTING IN A LOSS OF STIMULATION WERE CAUSED BY THE LEAD FRACTURE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218300, MODEL: SC-2218-30, SERIAL: (B)(6), BATCH: 17767347. PRODUCT FAMILY: SCS-IPG-R, UPN: M365SC1110020, MODEL: SC-1110-02, SERIAL: (B)(6), BATCH: 17349710. PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138550, MODEL: SC-3138-55, SERIAL: (B)(6), BATCH: 17424659. PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138550, MODEL: SC-3138-55, SERIAL: (B)(6), BATCH: 17424659.
DEVICE ANALYSIS PERFORMED ON THE RETURNED LEAD SC-2218-30, SERIAL: (B)(6) REVEALED THAT THE PROXIMAL END WAS BENT/FRACTURED BETWEEN THE SEVENTH AND EIGHTH CONTACTS. X-RAY INSPECTION REVEALED THAT ONE OF THE CABLES WAS FRACTURED WITHIN THE PROXIMAL ARRAY LIKELY DUE TO EXCESSIVE MECHANICAL FORCE BEING EXERTED ONTO THE LEAD DURING INSERTION INTO THE IPG PORT WHICH CAUSED DAMAGE TO THE INTERNAL CABLE. BASED ON ALL AVAILABLE INFORMATION, ENGINEERS CONCLUDED THAT THE HIGH IMPEDANCE MEASUREMENTS RESULTING IN A LOSS OF STIMULATION WAS LIKELY DUE TO EXCESSIVE FORCE EXERTED ONTO THE LEAD DURING INSERTION INTO THE IPG PORT WHICH RESULTED IN A FRACTURE OF THE LEAD. DEVICE ANALYSIS PERFORMED ON THE RETURNED IPG REVEALED NORMAL DEVICE CHARACTERISTICS AND PASSED VISUAL AND FUNCTIONAL TESTING. A LABELING REVIEW WAS CONDUCTED WHICH DETERMINED THAT LEAD BREAKAGE, HARDWARE ISSUES, LOOSE CONNECTIONS, AND ELECTRICAL ISSUES CAN RESULT IN INEFFECTIVE PAIN CONTROL AND ARE KNOWN RISKS ASSOCIATED WITH THE USE OF THE SCS DEVICE, AS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218300, MODEL: SC-2218-30, SERIAL: (B)(6), BATCH: 17767347. PRODUCT FAMILY: SCS-IPG-R, UPN: M365SC1110020, MODEL: SC-1110-02, SERIAL: (B)(6), BATCH: 17349710. PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138550, MODEL: SC-3138-55, SERIAL: (B)(6), BATCH: 17424659. PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138550, MODEL: SC-3138-55, SERIAL: (B)(6), BATCH: 17424659.
BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN MAY 2023 ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218300. MODEL: SC-2218-30 . SERIAL: (B)(6). BATCH: 17767347. PRODUCT FAMILY: SCS-IPG-R. UPN: M365SC1110020. MODEL: SC-1110-02 . SERIAL: (B)(6). BATCH: 17349710. PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138550. MODEL: SC-3138-55. SERIAL: (B)(6). BATCH: 17424659. PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138550. MODEL: SC-3138-55 . SERIAL: (B)(6). BATCH: 17424659.
B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218300. MODEL: SC-2218-30. SERIAL: (B)(6). BATCH: 17767347.
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED A RETURN OF PAIN AFTER THE STIMULATION COULD NO LONGER BE FELT. THE SCS WAS RESET WHICH RESUMED STIMULATION. IT WAS UNKNOWN HOW THE STIMULATION SETTING CHANGED. BASED ON IMPEDANCE MEASUREMENTS WITH THE CLINICIAN PROGRAMMER (CP), IT WAS DETERMINED THAT THE LEAD WAS FRACTURED IN MULTIPLE AREAS HOWEVER IMAGING WAS NOT TAKEN. NO FURTHER ACTION WILL BE TAKEN; THE PATIENT WILL CONTINUE TO USE SCS AS NORMAL.
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED A RETURN OF PAIN AFTER THE STIMULATION COULD NO LONGER BE FELT. THE SCS WAS RESET WHICH RESUMED STIMULATION. IT WAS UNKNOWN HOW THE STIMULATION SETTING CHANGED. BASED ON IMPEDANCE MEASUREMENTS WITH THE CLINICIAN PROGRAMMER (CP), IT WAS DETERMINED THAT THE LEAD WAS FRACTURED IN MULTIPLE AREAS HOWEVER IMAGING WAS NOT TAKEN. NO FURTHER ACTION WILL BE TAKEN; THE PATIENT WILL CONTINUE TO USE SCS AS NORMAL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LOSS OF STIMULATION WAS ASSESSED AS DUE TO THE PATIENTS POSTURE CAUSING A SLIGHT SHIFT IN THE LEAD POSITION.
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED A RETURN OF PAIN AFTER THE STIMULATION COULD NO LONGER BE FELT. THE SCS WAS RESET WHICH RESUMED STIMULATION. IT WAS UNKNOWN HOW THE STIMULATION SETTING CHANGED. BASED ON IMPEDANCE MEASUREMENTS WITH THE CLINICIAN PROGRAMMER (CP), IT WAS DETERMINED THAT THE LEAD WAS FRACTURED IN MULTIPLE AREAS HOWEVER IMAGING WAS NOT TAKEN. NO FURTHER ACTION WILL BE TAKEN; THE PATIENT WILL CONTINUE TO USE SCS AS NORMAL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LOSS OF STIMULATION WAS ASSESSED AS DUE TO THE PATIENTS POSTURE CAUSING A SLIGHT SHIFT IN THE LEAD POSITION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INADEQUATE THERAPEUTIC EFFECT OF THE SCS SYSTEM. THE IMPLANTABLE PULSE GENERATOR (IPG), LEADS AND LEAD EXTENSIONS WERE EXPLANTED. THERE WERE NO REPORTED PATIENT COMPLICATIONS POSTOPERATIVELY.
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED A RETURN OF PAIN AFTER THE STIMULATION COULD NO LONGER BE FELT. THE SCS WAS RESET WHICH RESUMED STIMULATION. IT WAS UNKNOWN HOW THE STIMULATION SETTING CHANGED. BASED ON IMPEDANCE MEASUREMENTS WITH THE CLINICIAN PROGRAMMER (CP), IT WAS DETERMINED THAT THE LEAD WAS FRACTURED IN MULTIPLE AREAS HOWEVER IMAGING WAS NOT TAKEN. NO FURTHER ACTION WILL BE TAKEN; THE PATIENT WILL CONTINUE TO USE SCS AS NORMAL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LOSS OF STIMULATION WAS ASSESSED AS DUE TO THE PATIENTS POSTURE CAUSING A SLIGHT SHIFT IN THE LEAD POSITION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INADEQUATE THERAPEUTIC EFFECT OF THE SCS SYSTEM. THE IMPLANTABLE PULSE GENERATOR (IPG), LEADS AND LEAD EXTENSIONS WERE EXPLANTED. THERE WERE NO REPORTED PATIENT COMPLICATIONS POSTOPERATIVELY.
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED A RETURN OF PAIN AFTER THE STIMULATION COULD NO LONGER BE FELT. THE SCS WAS RESET WHICH RESUMED STIMULATION. IT WAS UNKNOWN HOW THE STIMULATION SETTING CHANGED. BASED ON IMPEDANCE MEASUREMENTS WITH THE CLINICIAN PROGRAMMER (CP), IT WAS DETERMINED THAT THE LEAD WAS FRACTURED IN MULTIPLE AREAS HOWEVER IMAGING WAS NOT TAKEN. NO FURTHER ACTION WILL BE TAKEN; THE PATIENT WILL CONTINUE TO USE SCS AS NORMAL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LOSS OF STIMULATION WAS ASSESSED AS DUE TO THE PATIENTS POSTURE CAUSING A SLIGHT SHIFT IN THE LEAD POSITION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INADEQUATE THERAPEUTIC EFFECT OF THE SCS SYSTEM. THE IMPLANTABLE PULSE GENERATOR (IPG), LEADS AND LEAD EXTENSIONS WERE EXPLANTED. THERE WERE NO REPORTED PATIENT COMPLICATIONS POSTOPERATIVELY.
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED A RETURN OF PAIN AFTER THE STIMULATION COULD NO LONGER BE FELT. THE SCS WAS RESET WHICH RESUMED STIMULATION. IT WAS UNKNOWN HOW THE STIMULATION SETTING CHANGED. BASED ON IMPEDANCE MEASUREMENTS WITH THE CLINICIAN PROGRAMMER (CP), IT WAS DETERMINED THAT THE LEAD WAS FRACTURED IN MULTIPLE AREAS HOWEVER IMAGING WAS NOT TAKEN. NO FURTHER ACTION WILL BE TAKEN; THE PATIENT WILL CONTINUE TO USE SCS AS NORMAL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LOSS OF STIMULATION WAS ASSESSED AS DUE TO THE PATIENTS POSTURE CAUSING A SLIGHT SHIFT IN THE LEAD POSITION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INADEQUATE THERAPEUTIC EFFECT OF THE SCS SYSTEM. THE IMPLANTABLE PULSE GENERATOR (IPG), LEADS AND LEAD EXTENSIONS WERE EXPLANTED. THERE WERE NO REPORTED PATIENT COMPLICATIONS POSTOPERATIVELY.
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED A RETURN OF PAIN AFTER THE STIMULATION COULD NO LONGER BE FELT. THE SCS WAS RESET WHICH RESUMED STIMULATION. IT WAS UNKNOWN HOW THE STIMULATION SETTING CHANGED. BASED ON IMPEDANCE MEASUREMENTS WITH THE CLINICIAN PROGRAMMER (CP), IT WAS DETERMINED THAT THE LEAD WAS FRACTURED IN MULTIPLE AREAS HOWEVER IMAGING WAS NOT TAKEN. NO FURTHER ACTION WILL BE TAKEN. THE PATIENT WILL CONTINUE TO USE SCS AS NORMAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1197397 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-30 | 17767347 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Female | Required Intervention |