FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 18274154
·
Received December 6, 2023
Report
- Report Number
- 3006630150-2023-07660
- Event Type
- Injury
- Date Received
- December 6, 2023
- Date of Event
- November 13, 2023
- Report Date
- December 6, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, 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: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(6); BATCH: 7093480.
Description of Event or Problem · 0
IT WAS REPORTED THAT AN X-RAY WAS TAKEN AND REVEALED THAT ONE LEAD HAD MIGRATED DOWN AND LATERALLY TO ITS ORIGINAL PLACEMENT. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHEREIN THE LEADS WERE PLACED BACK TO WHERE THEY WERE ORIGINALLY PLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1264909 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | 7088698 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Female | Required Intervention |