FDA Adverse Event
Injury
Summary report: N
INFINION CX
MDR report key: 17302994
·
Received July 11, 2023
Report
- Report Number
- 3006630150-2023-04041
- Event Type
- Injury
- Date Received
- July 11, 2023
- Date of Event
- July 27, 2022
- Report Date
- July 11, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729861638
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: INFINION CX, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7071251.
Description of Event or Problem · 0
IT WAS REPORTED THAT HIGH IMPEDANCES WERE NOTED ON BOTH SPINAL CORD STIMULATION LEADS. REPROGRAMMING WAS INITIALLY SUCCESSFUL, HOWEVER, EVENTUALLY PATIENT HAD NO STIMULATION AND EXPERIENCED AN INCREASE IN PAIN. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEADS WERE REMOVED AND REPLACED. POST OPERATIVELY, THE PATIENT WAS NOTED TO HAVE RECOVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 756584 | INFINION CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2317-70 | 5135342 | 08714729861638 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |