FDA Adverse Event
Injury
Summary report: N
INFINION 16
MDR report key: 18603560
·
Received January 29, 2024
Report
- Report Number
- 3006630150-2024-00327
- Event Type
- Injury
- Date Received
- January 29, 2024
- Date of Event
- January 6, 2024
- Report Date
- January 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
- MO, 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: 7230363.
Description of Event or Problem · 0
IT WAS REPORTED THAT FOLLOWING AN IMPLANT PROCEDURE THE PATIENTS HEART RATE SPIKED. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH DIAGNOSIS OF ATRIAL FIBRILLATION. THE PHYSICIAN BELIEVED THAT THE PATIENTS ISSUE WAS NOT PROCEDURE RELATED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2538265 | INFINION 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2316-50E | 7225593 | 08714729797807 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female | Required Intervention |