FDA Adverse Event
Injury
Summary report: N
INFINION 16
MDR report key: 20138597
·
Received September 4, 2024
Report
- Report Number
- 3006630150-2024-05872
- Event Type
- Injury
- Date Received
- September 4, 2024
- Date of Event
- August 13, 2024
- Report Date
- September 4, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729837145
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- 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: M365SC231670E0. MODEL: SC-2316-70E. SERIAL: (B)(6). BATCH: 7090163.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE ENTRY SITE IN THE LOWER BACK THAT WAS MAKING IT DIFFICULT FOR THE PATIENT TO SLEEP AT NIGHT. THE PATIENT HAD A LEAD PULL, AND ALL EXPLANTED LEADS WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 899132 | INFINION 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2316-70E | 7089793 | 08714729837145 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Female | Required Intervention |