FDA Adverse Event
Injury
Summary report: N
INFINION CX
MDR report key: 9716385
·
Received February 17, 2020
Report
- Report Number
- 3006630150-2020-00597
- Event Type
- Injury
- Date Received
- February 17, 2020
- Date of Event
- January 27, 2020
- Report Date
- February 17, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729861638
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MODEL NUMBER/CATALOG NUMBER: SC-2317-70; SERIAL NUMBER: (B)(4); BATCH/LOT NUMBER: 3161196; MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 70CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENTS STIMULATION HAD SHIFTED DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 180822 | INFINION CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2317-70 | 3159883 | 08714729861638 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |