FDA Adverse Event
Injury
Summary report: N
INFINION CX
MDR report key: 9020715
·
Received September 13, 2019
Report
- Report Number
- 3006630150-2019-05026
- Event Type
- Injury
- Date Received
- September 13, 2019
- Date of Event
- July 30, 2019
- Report Date
- September 13, 2019
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729861614
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MODEL NUMBER/CATALOG NUMBER: SC-2317-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5142677, MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENTS LEAD HAD MIGRATED WHICH RESULTED LOW IMPEDANCE AND INADEQUATE STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPOSITIONED. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 820977 | INFINION CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2317-50 | 5109448 | 08714729861614 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |