FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA
MDR report key: 17134179
·
Received June 15, 2023
Report
- Report Number
- 3006630150-2023-03412
- Event Type
- Injury
- Date Received
- June 15, 2023
- Date of Event
- April 7, 2022
- Report Date
- June 15, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 7070296 / 7071891.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND INCREASING PAIN DESPITE THE REPROGRAMMING DONE. IT WAS ALSO NOTED THAT ONE OF THE PATIENTS LEADS HAD MIGRATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1230712 | WAVEWRITER ALPHA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1232 | 510964 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Male | Required Intervention |