FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 18384334
·
Received December 22, 2023
Report
- Report Number
- 3006630150-2023-08089
- Event Type
- Injury
- Date Received
- December 22, 2023
- Date of Event
- August 28, 2023
- Report Date
- December 22, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 5030707. PRODUCT FAMILY: SCS-IPG-R-MRI, UPN: M365SC12320, MODEL: SC-1232, SERIAL: (B)(6), BATCH: 529768.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE AND RIB STIMULATION DUE TO HIGH IMPEDANCES ON THE LEAD. IT WAS ALSO NOTED THAT THE PATIENT WAS FREQUENTLY CHARGING THE IPG. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1298928 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | 5012735 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Female | Required Intervention |