FDA Adverse Event
Injury
Summary report: N
INFINION 16
MDR report key: 19008530
·
Received March 29, 2024
Report
- Report Number
- 3006630150-2024-01937
- Event Type
- Injury
- Date Received
- March 29, 2024
- Date of Event
- March 8, 2024
- Report Date
- March 29, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729797807
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC231650E0 MODEL: SC-2316-50E SERIAL: (B)(6) BATCH: 7234090.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS GETTING A PROCEDURAL PAIN FROM A TRIAL PROCEDURE. THE PATIENT HAD A LEAD PULL PROCEDURE. THE EXPLANTED DEVICES WERE NOT RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2583883 | INFINION 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2316-50E | 7234019 | 08714729797807 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Female | Required Intervention |