WAVEWRITER ALPHA 16
Report
- Report Number
- 3006630150-2023-01040
- Event Type
- Injury
- Date Received
- March 6, 2023
- Date of Event
- February 13, 2023
- Report Date
- April 13, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729985082
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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: 7100009/7100010.
SC-1216 SN: (B)(6). THE RETURNED IPG WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE REPORTED EVENT WAS NOT CONFIRMED. THE IPG EXHIBITS NORMAL CHARACTERISTICS DURING THE ANALYSIS. HOWEVER, A LABELING REVIEW FOUND THAT THE REPORTED EVENT OF BURNING SENSATION DESPITE REPROGRAMMING IS A KNOWN RISK ASSOCIATED WITH THE USE OF AN IMPLANTABLE PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION. THEREFORE, THIS INVESTIGATION IS ASSIGNED A PROBABLE CAUSE OF KNOWN INHERENT RISK OF DEVICE.
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING BURNING SENSATION DESPITE REPROGRAMMING DONE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING BURNING SENSATION DESPITE REPROGRAMMING DONE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1512348 | WAVEWRITER ALPHA 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1216 | 526715 | 08714729985082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Unknown | Required Intervention |