FDA Adverse Event
Injury
Summary report: N
INFINION CX
MDR report key: 19678922
·
Received July 5, 2024
Report
- Report Number
- 3006630150-2024-04337
- Event Type
- Injury
- Date Received
- July 5, 2024
- Date of Event
- March 19, 2024
- Report Date
- July 5, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729861614
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: 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)(6), BATCH: 7071948.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT INADEQUATE STIMULATION DUE TO HIGH IMPEDANCES ON THE LEFT LEAD. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WILL NOT BE RETURNED PER HOSPITAL POLICY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1282101 | INFINION CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2317-50 | 3160293 | 08714729861614 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Female | Required Intervention |