FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 10157827
·
Received June 16, 2020
Report
- Report Number
- 3006630150-2020-02471
- Event Type
- Injury
- Date Received
- June 16, 2020
- Date of Event
- May 22, 2020
- Report Date
- June 16, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: LINEAR ST UPN: (B)(4), MODEL: SC-2218-50, SERIAL:(B)(4), BATCH: 5103150.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMEN STIMULATION. IT IS BELIEVED THAT PATIENT EXPERIENCED THIS DUE TO SCAR TISSUE. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE THE LEADS WERE REPOSITIONED. THE PATIENT IS DOING WELL POST-OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 621950 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | 5042719 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |