FDA Adverse Event
Injury
Summary report: N
INFINION CX
MDR report key: 9129893
·
Received September 27, 2019
Report
- Report Number
- 3006630150-2019-05374
- Event Type
- Injury
- Date Received
- September 27, 2019
- Date of Event
- September 6, 2019
- Report Date
- September 27, 2019
- 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
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2317-70, SERIAL: (B)(4), BATCH: 5071106.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENTS LEADS HAD MIGRATED, AND PAIN COVERAGE WAS LOST. THE PHYSICIAN DECIDED TO PERFORM A REVISION PROCEDURE TO MOVE THE LEADS DOWN. PATIENT WAS DOING WELL POST OPERATIVELY AND RECEIVING GOOD COVERAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 922922 | INFINION CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2317-70 | 21105996 | 08714729861638 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |