FDA Adverse Event
Injury
Summary report: N
INFINION 16
MDR report key: 8296829
·
Received February 1, 2019
Report
- Report Number
- 3006630150-2019-00328
- Event Type
- Injury
- Date Received
- February 1, 2019
- Date of Event
- January 11, 2019
- Report Date
- February 1, 2019
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729797807
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MODEL NUMBER/CATALOG NUMBER: SC-2316-50E, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5101309, MODEL/CATALOG DESCRIPTION: INFINION 16 TRIAL LEAD KIT 50 CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT HAD EXPERIENCED SHOCKING SENSATION AND BLEEDING AT THE INCISION SITE. THE PATIENT HAD AN EARLY LEAD PULL. IT WAS UNKNOWN IF MEDICAL INTERVENTION WAS PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 89659 | INFINION 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2316-50E | 5101302 | 08714729797807 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |