FDA Adverse Event
Injury
Summary report: N
INFINION 16
MDR report key: 18401002
·
Received December 27, 2023
Report
- Report Number
- 3006630150-2023-08170
- Event Type
- Injury
- Date Received
- December 27, 2023
- Date of Event
- December 4, 2023
- Report Date
- December 27, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729797807
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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: M365SC231650E0. MODEL: SC-2316-50E. SERIAL: (B)(6). BATCH: 7222510.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCREASED AMOUNT OF PAIN DURING THE TRIAL PERIOD. THE PATIENT UNDERWENT A LEAD PULL PROCEDURE. THE EXPLANTED LEADS WILL NOT BE RETURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1610880 | INFINION 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2316-50E | 7222263 | 08714729797807 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Male | Required Intervention |