LINEAR 3-4
Report
- Report Number
- 3006630150-2021-01218
- Event Type
- Injury
- Date Received
- March 25, 2021
- Date of Event
- March 11, 2021
- Report Date
- January 14, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729784067
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2352500. MODEL: SC-2352-50. SERIAL: (B)(6). BATCH: 7070470.
CORRECTION TO THE SUPPLEMENTAL 3 MDR IN BLOCK(S): B5, D4 ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2352700. MODEL: SC-2352-70. SERIAL: (B)(6). BATCH: 7071043. DEVICE TECHNICAL ANALYSIS: MODEL SC-2352-70 SERIAL (B)(6). X-RAY INSPECTION OF THE LEAD REVEALED THAT THE CABLE FOR ELECTRODE #7 WAS FRACTURED AT A WELD POINT WITHIN THE DISTAL ARRAY. THERE ARE NO EXPOSED CABLES AT THE FRACTURE LOCATION. LABORATORY ANALYSIS DETERMINED THAT THE LEAD BECAME DAMAGED DUE TO EXCESSIVE MECHANICAL FORCE OR MOVEMENT THAT CAUSED THE CABLES TO FRACTURE. MODEL SC-2352-70 SERIAL (B)(6). X-RAY INSPECTION OF THE LEAD REVEALED THAT THE CABLES FOR ELECTRODE #7 AND ELECTRODE #8 WERE FRACTURED AT A WELD POINT WITHIN THE DISTAL ARRAY. THERE ARE NO EXPOSED CABLES AT THE FRACTURE LOCATION. LABORATORY ANALYSIS DETERMINED THAT THE LEAD BECAME DAMAGED DUE TO EXCESSIVE MECHANICAL FORCE OR MOVEMENT THAT CAUSED THE CABLES TO FRACTURE. INVESTIGATION CONCLUSION: BASED ON ALL AVAILABLE INFORMATION, ENGINEERS CONCLUDED THAT THE INADEQUATE STIMULATION WAS CAUSED BY A LEAD FRACTURE. LABORATORY ANALYSIS DETERMINED THAT THE LEAD BECAME DAMAGED DUE TO EXCESSIVE MECHANICAL FORCE OR MOVEMENT THAT CAUSED THE CABLES TO FRACTURE. BENDING OF THE DISTAL ARRAY COULD POTENTIALLY CAUSE THE CABLE FRACTURE.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-2352-50E SERIAL/LOT: (B)(6). DESCRIPTION: LINEAR 3-4 TRIAL LEAD 50 CM INVESTIGATION SUMMARY WITH ALL AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED EVENT OF INADEQUATE STIMULATION COVERAGE WAS MOST LIKELY THE RESULT OF AN UNINTENDED USE ERROR THAT CAUSED OR CONTRIBUTED TO REPORTED EVENT. DEVICE HISTORY RECORD REVIEW A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEAD SERIAL NUMBERS: 7071043 AND 7070715 REVEALED NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. DEVICE TECHNICAL ANALYSIS THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE EXCHANGED, WHICH RESOLVED THE EVENT. THE LEADS WERE RETURNED FOR EVALUATION, X-RAYS WERE PERFORMED ON BOTH LEADS AND SHOWED FRACTURES ON AT THE DISTAL ENDS OF THE RIGHT CABLES AT THE WELD NUGGETS. THIS TYPE OF DAMAGE TYPICALLY OCCURS WHEN THE LEAD BODY IS SUBJECTED TO EXCESSIVE TENSILE FORCE RESULTING IN CABLE FRACTURES WITHIN THE DISTAL ARRAY. LABELLING REVIEW A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICES WERE USED PER THE INSTRUCTIONS FOR USE (IFU) PRODUCT LABELING. INVESTIGATION CONCLUSION INADEQUATE STIMULATION IS A KNOWN INHERENT RISK ASSOCIATED WITH USE OF THE DEVICE. PRODUCT LABELING STATES THAT LEAD MIGRATION RESULTING IN UNDESIRABLE CHANGES IN STIMULATION IS ONE OF THE POSSIBLE RISKS OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION. THE LEADS WERE RETURNED AND EVALUATED AS SUCH, PHYSICAL ANALYSIS WAS CONDUCTED BY THE LABORATORY AND CONFIRMED THE REPORTED EVENT. LABELING REVIEW WAS ALSO CONDUCTED. THIS REVIEW DETERMINED THAT INADEQUATE STIMULATION COVERAGE WAS LIKELY A RESULT OF AN UNINTENDED USE ERROR THAT CAUSED OR CONTRIBUTED TO REPORTED EVENT.
CORRECTION TO THE SUPPLEMENTAL 2 MDR IN BLOCK(S): H3, H6.
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INADEQUATE STIMULATION BEFORE AND AFTER DEVICE REPROGRAMMING. THE PHYSICIAN PERFORMED A LEAD EXCHANGE PROCEDURE AND THE PATIENT HAD GOOD PAIN COVERAGE.
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. AN ATTEMPT WAS MADE TO REPROGRAM THE PATIENT'S DEVICE, BUT STIMULATION STILL DID NOT COVER THE TARGETED AREAS. THE PATIENT UNDERWENT A REVISION PROCEDURE, AND THE REFERENCED LEADS (MODEL SC-2352-70 SERIAL (B)(6) AND MODEL SC-2352-70 SERIAL (B)(6) WERE EXPLANTED, REPLACED, AND RETURNED TO BSC FOR LABORATORY ANALYSIS. THE PATIENT HAD GOOD COVERAGE FOLLOWING THE REVISION PROCEDURE.
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INADEQUATE STIMULATION BEFORE AND AFTER DEVICE REPROGRAMMING. THE PHYSICIAN PERFORMED A LEAD EXCHANGE PROCEDURE AND THE PATIENT HAD GOOD PAIN COVERAGE.
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INADEQUATE STIMULATION BEFORE AND AFTER DEVICE REPROGRAMMING. THE PHYSICIAN PERFORMED A LEAD EXCHANGE PROCEDURE AND THE PATIENT HAD GOOD PAIN COVERAGE.
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INADEQUATE STIMULATION BEFORE AND AFTER DEVICE REPROGRAMMING. THE PHYSICIAN PERFORMED A LEAD EXCHANGE PROCEDURE AND THE PATIENT HAD GOOD PAIN COVERAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 468961 | LINEAR 3-4 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2352-70 | 7071039 | 08714729784067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male | Required Intervention |