FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 17958307
·
Received October 18, 2023
Report
- Report Number
- 3006630150-2023-06331
- Event Type
- Injury
- Date Received
- October 18, 2023
- Date of Event
- August 10, 2023
- Report Date
- October 18, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED ONE AND A HALF MONTHS AGO 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: 7120391.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS LEADS HAD MIGRATED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LINEAR LEADS WERE EXPLANTED, AND A NEW PADDLE LEAD WAS IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WAS NOT RETURNED PER FACILITY POLICY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 175713 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | 7116381 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male | Required Intervention |