AVISTA? MRI
Report
- Report Number
- 3006630150-2025-04869
- Event Type
- Injury
- Date Received
- June 26, 2025
- Date of Event
- June 5, 2025
- Report Date
- May 20, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729904816
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION UPN: M365SC3138550, MODEL: SC-3138-55, SERIAL: (B)(6), BATCH: 7132767.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION UPN: M365SC3138550 MODEL: SC-3138-55 SERIAL: (B)(6) BATCH: 7132767. THE LEAD WAS RETURNED AND ANALYZED VISUAL INSPECTION OF THE PROXIMAL END OF THE LEAD REVEALED THAT THE SPACER BETWEEN THE RETENTION SLEEVE AND CONTACT 8 WAS CRUSHED BY THE LEAD EXTENSION SETSCREW. IT APPEARS THAT THE ASSOCIATED LEAD WAS NOT FULLY INSERTED INTO THE LEAD EXTENSION WHEN THE SET SCREW WAS TIGHTENED. THE LEAD EXTENSION WAS RETURNED AND ANALYZED VISUAL INSPECTION REVEALED THAT THE LEAD EXTENSION WAS CLEANLY CUT INTO TWO PIECES APPROXIMATELY 15 CM FROM THE CONNECTOR SECTION OF THE LEAD EXTENSION. THE PROXIMAL TAIL OF THE LEAD EXTENSION AND THE CONNECTOR BLOCK OF THE LEAD EXTENSION WERE NOT RETURNED. A LABELING REVIEW WAS PERFORMED ON THE LEAD AND LEAD EXTENSIONS' INSTRUCTIONS FOR USE, IFU. THERE WAS NO EVIDENCE THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELED INDICATIONS. IT STATES ENSURE THAT THE LEAD IS FULLY INSERTED BEFORE TIGHTENING THE SETSCREW TO PREVENT LEAD DAMAGE. IT ALSO STATES AVOID DAMAGING THE LEAD WITH SHARP INSTRUMENTS OR EXCESSIVE FORCE DURING SURGERY AND ENSURE THAT THE LEAD IS FULLY INSERTED BEFORE TIGHTENING THE SETSCREW TO PREVENT LEAD DAMAGE. BASED ON ALL AVAILABLE INFORMATION, ENGINEERS ARE ABLE TO CONFIRM THE ROOT CAUSE OF THE EVENT. THE DEVICES WERE RETURNED AND ANALYZED, AS SUCH PHYSICAL ANALYSIS WAS CONDUCTED, RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. THEREFORE, THIS INVESTIGATION IS ABLE TO DETERMINE A PROBABLE ROOT CAUSE FOR THE COMPLAINT AND THE CONCLUSION IS UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138550. MODEL: SC-3138-55. SERIAL: (B)(6). BATCH: (B)(6). THE DEVICE HAS BEEN RECEIVED, BUT DEVICE ANALYSIS HAS NOT BEEN COMPLETED.
IT WAS REPORTED THAT AT THE END OF THE TRIAL PERIOD OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM WHILE INITIATING THE PERMANENT PHASE OF THE STIMULATION SYSTEM, THE PHYSICIAN ATTEMPTED TO DISCONNECT THE LEAD EXTENSION FROM THE LEAD, BY CUTTING THE LEAD EXTENSION. THE PHYSICIAN LOOSENED THE SET SCREW AND MADE VARIOUS ATTEMPTS BUT WAS UNSUCCESSFUL IN SEPARATING THE DEVICES NOTING SIGNIFICANT RESISTANCE. THE PHYSICIAN APPLIED FORCE TO THE LEAD AND DAMAGED THE CONNECTION POINT OF THE LEAD EXTENSION AND THE LEAD, NOTING THAT IN A PORTION OF THE LEAD EXTENSION REMAINED ATTACHED TO THE LEAD. THE PHYSICIAN THEN UTILIZED THE TORQUE WRENCH AND REALIZED THAT ONE OF THE SET SCREWS WAS STILL IN PLACE FIXING THE LEAD EXTENSION TO THE LEAD. DUE TO THE FORCE THE PHYSICIAN APPLIED TO THE LEAD HE DECIDED TO EXPLANT IT, AND COMPLETED THE PROCEDURE WITH A NEW DEVICE.
IT WAS REPORTED THAT AT THE END OF THE TRIAL PERIOD OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM WHILE INITIATING THE PERMANENT PHASE OF THE STIMULATION SYSTEM, THE PHYSICIAN ATTEMPTED TO DISCONNECT THE LEAD EXTENSION FROM THE LEAD, BY CUTTING THE LEAD EXTENSION. THE PHYSICIAN LOOSENED THE SET SCREW AND MADE VARIOUS ATTEMPTS BUT WAS UNSUCCESSFUL IN SEPARATING THE DEVICES NOTING SIGNIFICANT RESISTANCE. THE PHYSICIAN APPLIED FORCE TO THE LEAD AND DAMAGED THE CONNECTION POINT OF THE LEAD EXTENSION AND THE LEAD, NOTING THAT IN A PORTION OF THE LEAD EXTENSION REMAINED ATTACHED TO THE LEAD. THE PHYSICIAN THEN UTILIZED THE TORQUE WRENCH AND REALIZED THAT ONE OF THE SET SCREWS WAS STILL IN PLACE FIXING THE LEAD EXTENSION TO THE LEAD. DUE TO THE FORCE THE PHYSICIAN APPLIED TO THE LEAD HE DECIDED TO EXPLANT IT AND COMPLETED THE PROCEDURE WITH A NEW DEVICE.
IT WAS REPORTED THAT AT THE END OF THE TRIAL PERIOD OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM WHILE INITIATING THE PERMANENT PHASE OF THE STIMULATION SYSTEM, THE PHYSICIAN ATTEMPTED TO DISCONNECT THE LEAD EXTENSION FROM THE LEAD, BY CUTTING THE LEAD EXTENSION. THE PHYSICIAN LOOSENED THE SET SCREW AND MADE VARIOUS ATTEMPTS BUT WAS UNSUCCESSFUL IN SEPARATING THE DEVICES NOTING SIGNIFICANT RESISTANCE. THE PHYSICIAN APPLIED FORCE TO THE LEAD AND DAMAGED THE CONNECTION POINT OF THE LEAD EXTENSION AND THE LEAD, NOTING THAT IN A PORTION OF THE LEAD EXTENSION REMAINED ATTACHED TO THE LEAD. THE PHYSICIAN THEN UTILIZED THE TORQUE WRENCH AND REALIZED THAT ONE OF THE SET SCREWS WAS STILL IN PLACE FIXING THE LEAD EXTENSION TO THE LEAD. DUE TO THE FORCE THE PHYSICIAN APPLIED TO THE LEAD HE DECIDED TO EXPLANT IT AND COMPLETED THE PROCEDURE WITH A NEW DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 442449 | AVISTA? MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2408-56 | 7087105 | 08714729904816 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |