FDA Adverse Event
Injury
Summary report: N
LINEAR 3-4
MDR report key: 14699651
·
Received June 15, 2022
Report
- Report Number
- 3006630150-2022-02900
- Event Type
- Injury
- Date Received
- June 15, 2022
- Date of Event
- May 26, 2022
- Report Date
- June 15, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729789581
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
APPROXIMATED 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: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(4), BATCH: 7070767.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE DURING AN IPG REPLACEMENT PROCEDURE, IT WAS FOUND OUT THAT THE PATIENTS LEADS HAD HIGH IMPEDANCES. THE PHYSICIAN OPTED TO REPLACE THE LEADS AS WELL AND THE PATIENT WAS DOING GREAT POSTOPERATIVELY. THE EXPLANTED LEADS WERE DISCARDED PER HOSPITAL POLICY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1627101 | LINEAR 3-4 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2352-70 | 5140176 | 08714729789581 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Male | Required Intervention |