FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 17632644
·
Received August 28, 2023
Report
- Report Number
- 3006630150-2023-05105
- Event Type
- Injury
- Date Received
- August 28, 2023
- Date of Event
- August 3, 2023
- Report Date
- August 28, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767749
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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 COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 7091010.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS LEAD WAS REPOSITIONED TO GAIN BETTER COVERAGE OF THE PAIN ON THE LEFT SIDE. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 317445 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-70 | 7090683 | 08714729767749 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female | Required Intervention |