FDA Adverse Event
Injury
Summary report: N
INFINION CX
MDR report key: 11867358
·
Received May 21, 2021
Report
- Report Number
- 3006630150-2021-02320
- Event Type
- Injury
- Date Received
- May 21, 2021
- Date of Event
- March 4, 2021
- Report Date
- May 21, 2021
- 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
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 5160501. PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: M365SC43180, MODEL: SC-4318, BATCH: 23926534. PRODUCT FAMILY: SCS-IPG-R UPN: M365SC11600, MODEL: SC-1160, SERIAL: (B)(4), BATCH: 357388.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF STIMULATION AFTER UNDERGOING A NON DEVICE RELATED PROCEDURE. THE PHYSICIAN ASSESSED THAT THE LEADS HAD HIGH IMPEDANCES WITH X-RAY IMAGING HAVING CONFIRMED THE LEADS HAD ALSO MIGRATED. THE PATIENT UNDERWENT A REVISION PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 764076 | INFINION CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2317-50 | 5077554 | 08714729861614 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |