FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 20701404
·
Received November 16, 2024
Report
- Report Number
- 3006630150-2024-07911
- Event Type
- Injury
- Date Received
- November 16, 2024
- Date of Event
- July 2, 2024
- Report Date
- November 16, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: 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: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7110881.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS LUMBAR SPINAL CORD STIMULATION (SCS) LEAD HAD HIGH IMPEDANCE IN PORT D. IT DID NOT IMPACT DURING PROGRAMMING, AS THIS LEAD WAS NEVER USED. THE PATIENT UNDERWENT A LEAD EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WAS DISCARDED BY THE FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 93184 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2218-50 | 7110378 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male | Required Intervention |