FDA Adverse Event
Injury
Summary report: N
INFINION CX
MDR report key: 14633264
·
Received June 8, 2022
Report
- Report Number
- 3006630150-2022-02758
- Event Type
- Injury
- Date Received
- June 8, 2022
- Date of Event
- April 7, 2022
- Report Date
- June 8, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729861614
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 5093106.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT HAD NO STIMULATION ON THE LEFT SIDE DUE TO FAILED SPINAL CORD STIMULATOR LEADS. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. NO DEVICE MALFUNCTION SUSPECTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26217 | INFINION CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2317-50 | 5086675 | 08714729861614 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Male | Required Intervention |