WAVEWRITER ALPHA?
Report
- Report Number
- 3006630150-2025-04900
- Event Type
- Injury
- Date Received
- June 27, 2025
- Date of Event
- June 3, 2025
- Report Date
- September 16, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8336500 MODEL: SC-8336-50 SERIAL: (B)(6). BATCH: 7090703 UDI: (B)(4).
IT WAS REPORTED THAT THE PATIENT INFORMED OF BEING ADMITTED FOLLOWING THE IMPLANT PROCEDURE DUE TO SEVERE STOMACHACHE AND CONSTIPATION. THE PATIENT WAS ADMINISTERED WITH LAXATIVES AND HAS SINCE BEEN DISCHARGED. IT WAS ALSO NOTED THAT THE PATIENT DEVELOPED PROGRESSIVE ITCHING AT THE BACK WHICH WAS NOT DEVICE RELATED AND WAS MOST LIKELY DUE TO THE MEDICATIONS GIVEN. UPON FOLLOW-UP, THE SYMPTOMS HAVE COMPLETELY RESOLVED.
IT WAS REPORTED THAT THE PATIENT INFORMED OF BEING ADMITTED FOLLOWING THE IMPLANT PROCEDURE DUE TO SEVERE STOMACHACHE AND CONSTIPATION. THE PATIENT WAS ADMINISTERED WITH LAXATIVES AND HAS SINCE BEEN DISCHARGED. IT WAS ALSO NOTED THAT THE PATIENT DEVELOPED PROGRESSIVE ITCHING AT THE BACK WHICH WAS NOT DEVICE RELATED AND WAS MOST LIKELY DUE TO THE MEDICATIONS GIVEN. UPON FOLLOW-UP, THE SYMPTOMS HAVE COMPLETELY RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1803418 | WAVEWRITER ALPHA? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1232 | 764761 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Female | Required Intervention| H |