FDA Adverse Event
Injury
Summary report: N
INFINION CX
MDR report key: 18395151
·
Received December 26, 2023
Report
- Report Number
- 3006630150-2023-08145
- Event Type
- Injury
- Date Received
- December 26, 2023
- Date of Event
- April 25, 2023
- Report Date
- December 26, 2023
- 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
- IN, 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: M365SC2317700; MODEL: SC-2317-70; SERIAL: (B)(6) ; BATCH: 5141329. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R; UPN: M365SC11600; MODEL: SC-1160; SERIAL: (B)(6) BATCH: 354205.
Description of Event or Problem · 0
IT WAS REPORTED THAT PATIENTS LEAD HAD MULTIPLE CONTACTS OUT. IT WAS NOTED ALSO THAT PATIENTS HAD DIFFICULTY CHARGING THE IPG. THE PATIENT UNDERWENT A LEAD AND IPG REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1489243 | INFINION CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2317-70 | 5140022 | 08714729861638 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 92 YR | Female | Required Intervention |