FDA Adverse Event
Injury
Summary report: N
LINEAR 3-6
MDR report key: 20772240
·
Received November 25, 2024
Report
- Report Number
- 3006630150-2024-08128
- Event Type
- Injury
- Date Received
- November 25, 2024
- Date of Event
- October 30, 2024
- Report Date
- November 25, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729789567
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2366700. MODEL: SC-2366-70. SERIAL: (B)(6). BATCH: 7070726/7070798/7070894.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE RIGHT DELTOID INCISION SITE. NO KNOWN SYMPTOM WAS REPORTED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) LEAD EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1630456 | LINEAR 3-6 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2366-70 | 5136417 | 08714729789567 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male | Required Intervention |