FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 14748355
·
Received June 20, 2022
Report
- Report Number
- 3006630150-2022-02990
- Event Type
- Injury
- Date Received
- June 20, 2022
- Date of Event
- May 9, 2022
- Report Date
- June 20, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
EVENT DATE: EXACT DATE UNKNOWN, EVENT OCCURRED LAST WEEK FROM THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: CS-LINEAR LEADS; UPN: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(4); BATCH: 5132824.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS LEADS WERE MIGRATED ABOVE THE ANCHOR AND UNDERWENT A LEAD REVISION PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1135506 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | 5132823 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Female | Required Intervention |