LINEAR ST
Report
- Report Number
- 3006630150-2025-03516
- Event Type
- Injury
- Date Received
- May 20, 2025
- Date of Event
- April 29, 2025
- Report Date
- June 27, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729820741
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC221870E0, MODEL: SC-2218-70E, SERIAL: (B)(6), BATCH: 7103732.
ADDITIONAL INFORMATION PROVIDED IN BLOCK H6 ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC221870E0 MODEL: SC-2218-70E SERIAL: (B)(6). BATCH: 7103732.
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) TRIAL PATIENT WAS TAKEN TO THE EMERGENCY ROOM DUE TO A POSSIBLE STROKE AND THROMBOSIS. THE PATIENT EXPERIENCED SLURRED SPEECH AND IMMOBILITY OF THE RIGHT ARM. THE PHYSICIAN ASSESSED THAT THE DEVICE NOR THE PROCEDURE CAUSED OR CONTRIBUTED TO THE PATIENTS COMPLICATIONS AS THE PATIENT HAD SUSPENDED THEIR PRE-EXISTING ANTICOAGULANT MEDICATION FOR A PROLONGED PERIOD OF TIME PRIOR TO THE TRIAL PROCEDURE. THE PATIENTS TRIAL LEADS WERE REMOVED THE DAY AFTER THE PATIENTS SYMPTOMS BEGAN AND THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL. ADDITIONALLY, THE PATIENT WAS PLACED BACK ON THEIR ANTICOAGULANT MEDICATION ONCE AGAIN AND HAS SINCE RECOVERED. THE REMOVED TRIAL LEADS WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE MEDICAL FACILITY.
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) TRIAL PATIENT WAS TAKEN TO THE EMERGENCY ROOM DUE TO A POSSIBLE STROKE AND THROMBOSIS. THE PATIENT EXPERIENCED SLURRED SPEECH AND IMMOBILITY OF THE RIGHT ARM. THE PHYSICIAN ASSESSED THAT THE DEVICE NOR THE PROCEDURE CAUSED OR CONTRIBUTED TO THE PATIENTS COMPLICATIONS AS THE PATIENT HAD SUSPENDED THEIR PRE-EXISTING ANTICOAGULANT MEDICATION FOR A PROLONGED PERIOD OF TIME PRIOR TO THE TRIAL PROCEDURE. THE PATIENTS TRIAL LEADS WERE REMOVED THE DAY AFTER THE PATIENTS SYMPTOMS BEGAN AND THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL. ADDITIONALLY, THE PATIENT WAS PLACED BACK ON THEIR ANTICOAGULANT MEDICATION ONCE AGAIN AND HAS SINCE RECOVERED. THE REMOVED TRIAL LEADS WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 724046 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2218-70E | 7103264 | 08714729820741 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male | Hospitalization| R |