FDA Adverse Event
Malfunction
Summary report: N
INFINION CX
MDR report key: 9826000
·
Received March 12, 2020
Report
- Report Number
- 3006630150-2020-01164
- Event Type
- Malfunction
- Date Received
- March 12, 2020
- Date of Event
- February 13, 2020
- Report Date
- March 12, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729861638
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MODEL NUMBER/ CATALOG NUMBER: SC-2317-70, SERIAL NUMBER: (B)(4), BATCH/ LOT NUMBER: 5162869, MODEL/ CATALOG DESCRIPTION: INFINION CX LEAD KIT, 70CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING LOSS OF STIMULATION DUE TO HIGH LEAD IMPEDANCES. X-RAY WAS TAKEN AND REVEALED MIGRATION OF THE LEADS. IT WAS ALSO REPORTED THAT THE PATIENT HAD A FALL THAT RESULTED TO LEAD FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 285720 | INFINION CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2317-70 | 5147411 | 08714729861638 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |