FDA Adverse Event
Malfunction
Summary report: N
LINEAR 3-4
MDR report key: 17891559
·
Received October 6, 2023
Report
- Report Number
- 3006630150-2023-06094
- Event Type
- Malfunction
- Date Received
- October 6, 2023
- Date of Event
- November 14, 2022
- Report Date
- October 6, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729789581
- PMA / PMN Number
- P030017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED APPROXIMATELY TEN MONTHS AGO. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2352700. MODEL: SC-2352-70. SERIAL: (B)(6). BATCH: 7070293.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT HAD A SUSPECTED LEAD FRACTURE. IT WAS UNKNOWN IF THE LEAD FRACTURE WAS CONFIRMED THROUGH IMAGING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 202076 | LINEAR 3-4 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2352-70 | 5136022 | 08714729789581 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Female | Other |