FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA 16
MDR report key: 16413799
·
Received February 21, 2023
Report
- Report Number
- 3006630150-2023-00715
- Event Type
- Injury
- Date Received
- February 21, 2023
- Date of Event
- December 22, 2022
- Report Date
- February 21, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729985082
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
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: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(4). BATCH: 7101867/7101869. PRODUCT FAMILY: SCS-LEAD FIXATION UPN: M365SC43160. MODEL: SC-4316. BATCH: 28303967.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND DISCOMFORT AT THE IPG AND ANCHOR SITES DUE TO THEIR POSITION. IT WAS ALSO REPORTED THAT THE PATIENT HAD DIFFICULTY MANAGING WITH THE PROGRAMMING ON THE DEVICE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED AND WERE NOT RETURNED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1229139 | WAVEWRITER ALPHA 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1216 | 529680 | 08714729985082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female | Required Intervention |