FDA Adverse Event
Injury
Summary report: N
INFINION 16
MDR report key: 14474061
·
Received May 23, 2022
Report
- Report Number
- 3006630150-2022-02398
- Event Type
- Injury
- Date Received
- May 23, 2022
- Date of Event
- April 28, 2022
- Report Date
- May 23, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729797807
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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)(4). BATCH: 7160116.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT STATED THAT DURING THE TRIAL PERIOD THE PAIN GOT WORSE, AND THE PATIENT WAS NOT GETTING PAIN RELIEF. THE PATIENT UNDERWENT AN EARLY LEAD PULL. THE TRIAL LEADS WERE DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 220165 | INFINION 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2316-50E | 7159733 | 08714729797807 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Male | Required Intervention |