FDA Adverse Event
Injury
Summary report: N
INFINION CX
MDR report key: 20679492
·
Received November 13, 2024
Report
- Report Number
- 3006630150-2024-07807
- Event Type
- Injury
- Date Received
- November 13, 2024
- Date of Event
- June 17, 2024
- Report Date
- November 13, 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
- CO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6), BATCH: 7082025.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AS WELL AS STIMULATION IN A NON-TARGET AREA. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN ONE OF THE LEADS WAS REPLACED AND REPOSITIONED. NO DEVICE MALFUNCTION WAS SUSPECTED. THE EXPLANTED LEAD WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1350777 | INFINION CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2317-70 | 7084249 | 08714729861638 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Female | Required Intervention |