FDA Adverse Event
Injury
Summary report: N
INFINION CX
MDR report key: 14059291
·
Received April 8, 2022
Report
- Report Number
- 3006630150-2022-01555
- Event Type
- Injury
- Date Received
- April 8, 2022
- Date of Event
- March 24, 2022
- Report Date
- April 8, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729861638
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- 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)(4), BATCH: 5102169.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO HIGH IMPEDANCES DISPLAYED ON THE LEADS. REPROGRAMMING WAS ATTEMPTED, HOWEVER THE ISSUE DID NOT RESOLVE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE BOTH LEADS WERE REPLACED. POST OPERATIVELY THE PATIENT WAS WELL. THE LEADS WILL NOT BE RETURNED TO BOSTON SCIENTIFIC AS THEY WERE RETAINED BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1282847 | INFINION CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2317-70 | 7071019 | 08714729861638 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |