FDA Adverse Event
Injury
Summary report: N
LINEAR 3-4
MDR report key: 12586660
·
Received October 6, 2021
Report
- Report Number
- 3006630150-2021-05604
- Event Type
- Injury
- Date Received
- October 6, 2021
- Date of Event
- August 26, 2021
- Report Date
- October 6, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729789550
- 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: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(4), BATCH: 7072931.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SPINAL CORD STIMULATION IMPLANT PROCEDURE, AN ATTEMPT WAS MADE TO PERFORM INTRAOPERATIVE TESTING OF THE LEADS, HOWEVER IT WAS NOT ABLE TO BE COMPLETED DUE TO THE PATIENT NOT BEING COOPERATIVE WHILE UNDER ANESTHESIA. DURING POST-OPERATIVE PROGRAMMING, THE STIMULATION THAT WAS PRODUCED WAS NOT ACCURATE TO THE PATIENT'S PAIN AREA. THE PATIENT UNDERWENT A REVISION PROCEDURE TO RE-POSITION THE LEADS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1480241 | LINEAR 3-4 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2352-50 | 7073002 | 08714729789550 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |