FDA Adverse Event
Injury
Summary report: N
INFINION CX
MDR report key: 21029077
·
Received December 27, 2024
Report
- Report Number
- 3006630150-2024-09068
- Event Type
- Injury
- Date Received
- December 27, 2024
- Date of Event
- October 1, 2024
- Report Date
- December 27, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729861638
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH:7080111.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EXPLANTED DUE TO HIGH IMPEDANCE ON LEADS. THE PATIENT IS DOING GREAT POST OPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED DUE TO FACILITY POLICY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1813487 | INFINION CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2317-70 | 7076290 | 08714729861638 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |