FDA Adverse Event
Injury
Summary report: N
INFINION 16
MDR report key: 10007055
·
Received April 28, 2020
Report
- Report Number
- 3006630150-2020-01909
- Event Type
- Injury
- Date Received
- April 28, 2020
- Date of Event
- April 24, 2019
- Report Date
- April 28, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729797807
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE (B)(6) 2019 WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. EXPLANT DATE: (B)(6) 2019. MODEL NUMBER/ CATALOG NUMBER: SC-2316-50E, SERIAL NUMBER: (B)(4), BATCH/ LOT NUMBER: 5122386, MODEL/ CATALOG DESCRIPTION: INFINION 16 TRIAL LEAD KIT 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION DURING TRIAL. IT WAS ALSO STATED THAT THE PATIENT'S TRIAL LEADS MIGRATED. THE PATIENT UNDERWENT A LEAD PULL PROCEDURE AND WILL UNDERGO A RETRIAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 470805 | INFINION 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2316-50E | 5116642 | 08714729797807 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |