FDA Adverse Event
Injury
Summary report: N
ARTISAN
MDR report key: 12459260
·
Received September 13, 2021
Report
- Report Number
- 3006630150-2021-05093
- Event Type
- Injury
- Date Received
- September 13, 2021
- Date of Event
- August 25, 2021
- Report Date
- September 13, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729779902
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 5110463/7078940.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE STIMULATION DUE TO LEAD MIGRATION. NO DEVICE MALFUNCTION WAS SUSPECTED. THE LEADS WERE REVISED AND REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1355889 | ARTISAN | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-8216-50 | 7072690 | 08714729779902 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention |