FDA Adverse Event
Injury
Summary report: N
LINEAR 3-6
MDR report key: 10323174
·
Received July 24, 2020
Report
- Report Number
- 3006630150-2020-03075
- Event Type
- Injury
- Date Received
- July 24, 2020
- Date of Event
- June 30, 2020
- Report Date
- July 24, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729789574
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 5136449. UPN: (B)(4), MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 5141394. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 5155266. PRODUCT FAMILY: SCS-IPG-R, UPN: (B)(4), MODEL: SC-1160, SERIAL: (B)(4), BATCH: 355002.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE SURGICAL SITE OF WHERE THE LEADS WERE PLACED, AND ALSO EXPERIENCING A LACK OF PAIN RELIEF FROM INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE TO EXPLANT THE IPG AND LEADS. THE PATIENT WAS DOING WELL POST OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 787149 | LINEAR 3-6 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2366-50 | 5135765 | 08714729789574 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |