INFINION? CX
Report
- Report Number
- 3006630150-2025-02748
- Event Type
- Injury
- Date Received
- April 24, 2025
- Date of Event
- April 3, 2025
- Report Date
- November 19, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729861638
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK B3: EXACT DATE UNKNOWN, BASED OFF BSC AWARE DATE.
ADDITIONAL INFORMATION PROVIDED IN BLOCKS B5, D4 AND H11. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 7080786. UDI: (B)(4). BLOCK B3: EXACT DATE UNKNOWN, BASED OFF BSC AWARE DATE.
DEVICE ANALYSIS WAS PERFORMED ON THE RETURNED LEADS SC-2317-70 SERIAL NUMBERS (B)(6). VISUAL INSPECTION OF THE LEAD SERIAL NUMBER (B)(6) REVEALED THAT IT WAS CLEANLY CUT INTO TWO PIECES APPROXIMATELY 24 CM FROM THE DISTAL END OF THE LEAD. THIS DAMAGE IS TYPICALLY A RESULT OF THE EXPLANT PROCEDURE AND IS NOT CONSIDERED AN ANOMALY. ELECTRICAL TESTING WAS UNABLE TO BE PERFORMED ON THIS LEAD DUE TO THE CUT LEAD BODY. NO OTHER ANOMALIES WERE IDENTIFIED ON THE RETURNED PORTION OF THE LEAD. ADDITIONALLY, VISUAL AND X-RAY INSPECTION OF LEAD SERIAL (B)(6) REVEALED THAT IT WAS BENT/KINKED NEAR THE SET SCREW MARK OF THE CLIK ANCHOR AND MULTIPLE CABLES WERE COMPLETELY BROKEN AT THE FRACTURE LOCATION. LABORATORY ANALYSIS DETERMINED THAT THE LEAD BECAME BENT/KINKED AT THE EXIT POINT OF THE CLIK ANCHOR, EXPOSING THE BENT LOCATION TO EXCESSIVE MECHANICAL FORCE THAT CAUSED THE CABLES TO FRACTURE AT THE ANCHOR POINT. A PRODUCT LABELING REVIEW THAT WAS CONDUCTED DETERMINED THAT LEAD BREAKAGE, LOOSE CONNECTIONS AND ELECTRICAL ISSUES CAN RESULT IN REDUCTION IN PAIN RELIEF AND IS A KNOWN RISK 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: M365SC2317700. MODEL: SC-2317-70 . SERIAL: (B)(6). BATCH: 7080864. UDI: (B)(4). BLOCK B3: EXACT DATE UNKNOWN, BASED OFF BSC AWARE DATE.
ADDITIONAL INFORMATION PROVIDED IN BLOCK H11 ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7080864, UDI: (B)(4). BLOCK B3: EXACT DATE UNKNOWN, BASED OFF BSC AWARE DATE.
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED A RETURN OF PRE-EXISTING PAIN IN THE BUTTOCK AND BOTH LEGS DUE TO INADEQUATE STIMULATION THAT WAS CAUSED BY HIGH IMPEDANCE READINGS ON THE LEAD. THEREFORE, THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE DURING WHICH THE LEAD WAS EXPLANTED AND TWO NEW LEADS WERE IMPLANTED. THE PATIENT HAS FULLY RECOVERED POSTOPERATIVELY.
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED A RETURN OF PRE-EXISTING PAIN IN THE BUTTOCK AND BOTH LEGS DUE TO INADEQUATE STIMULATION THAT WAS CAUSED BY HIGH IMPEDANCE READINGS ON THE LEAD. THEREFORE, THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE DURING WHICH THE LEAD WAS EXPLANTED AND TWO NEW LEADS WERE IMPLANTED. THE PATIENT HAS FULLY RECOVERED POSTOPERATIVELY. ADDITIONAL INFORMATION WAS PROVIDED THAT CLARIFIED DURING THE LEAD REVISION PROCEDURE TWO LEADS WERE EXPLANTED AND REPLACED WITH TWO NEW LEADS.
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED A RETURN OF PRE-EXISTING PAIN IN THE BUTTOCK AND BOTH LEGS DUE TO INADEQUATE STIMULATION THAT WAS CAUSED BY HIGH IMPEDANCE READINGS ON THE LEAD. THEREFORE, THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE DURING WHICH THE LEAD WAS EXPLANTED AND TWO NEW LEADS WERE IMPLANTED. THE PATIENT HAS FULLY RECOVERED POSTOPERATIVELY. ADDITIONAL INFORMATION WAS PROVIDED THAT CLARIFIED DURING THE LEAD REVISION PROCEDURE TWO LEADS WERE EXPLANTED AND REPLACED WITH TWO NEW LEADS.
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED A RETURN OF PRE-EXISTING PAIN IN THE BUTTOCK AND BOTH LEGS DUE TO INADEQUATE STIMULATION THAT WAS CAUSED BY HIGH IMPEDANCE READINGS ON THE LEAD. THEREFORE, THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE DURING WHICH THE LEAD WAS EXPLANTED AND TWO NEW LEADS WERE IMPLANTED. THE PATIENT HAS FULLY RECOVERED POSTOPERATIVELY. ADDITIONAL INFORMATION WAS PROVIDED THAT CLARIFIED DURING THE LEAD REVISION PROCEDURE TWO LEADS WERE EXPLANTED AND REPLACED WITH TWO NEW LEADS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1227979 | INFINION? CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2317-70 | 7080784 | 08714729861638 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |