FDA Adverse Event
Injury
Summary report: N
INFINION CX
MDR report key: 10362687
·
Received August 4, 2020
Report
- Report Number
- 3006630150-2020-03215
- Event Type
- Injury
- Date Received
- August 4, 2020
- Date of Event
- July 13, 2020
- Report Date
- August 4, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729861614
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4), MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 5100307. PRODUCT FAMILY: SCS-IPG-R: UPN: (B)(4), MODEL: SC-1160, SERIAL: (B)(4), BATCH: 340305.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN THERAPY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS POSITION WAS ADJUSTED AND ALSO THE IPG. THE PHYSICIAN DECIDED ALSO TO REPLACED THE IPG. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE IPG WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 829453 | INFINION CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2317-50 | 5097300 | 08714729861614 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Required Intervention |