WAVEWRITER ALPHA? 16
Report
- Report Number
- 3006630150-2026-00582
- Event Type
- Injury
- Date Received
- January 28, 2026
- Date of Event
- July 31, 2025
- Report Date
- April 16, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729985082
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6) BATCH: 7167344 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6) BATCH: 7164262 UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION UPN: M365SC43180 MODEL: SC-4318 BATCH: 36814326 UDI: (B)(4).
MODEL NUMBER/CATALOG NUMBER: SC-1216/ SC-2218-50/ SC-4318, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 790479/ 7167344/ 7164262/ 36814326. INVESTIGATION RESULTS THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE DEVICE, HOWEVER RESPONSE WAS NOT RECEIVED. DEVICE HISTORY RECORD IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. INVESTIGATION CONCLUSION BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.
IT WAS REPORTED THAT FOLLOWING THE PERMANENT IMPLANT PROCEDURE THE PATIENT HAD WOUND DEHISCENCE AND DEVELOPED AN INFECTION AT THE POCKET AND INCISION SITE IN WHICH CAUSED THE AREA TO SWELL AND REDNESS THAT PRODUCED A PURULENT DISCHARGE. IT WAS ALSO NOTED THAT THE PATIENT TO EXPERIENCED PAIN. THE PATIENT WAS PROVIDED WITH BACTRIM AND HAD RECOVERED. THE DEVICE REMAINS IMPLANTED AND IN SERVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED.
IT WAS REPORTED THAT FOLLOWING THE PERMANENT IMPLANT PROCEDURE THE PATIENT HAD WOUND DEHISCENCE AND DEVELOPED AN INFECTION AT THE POCKET AND INCISION SITE IN WHICH CAUSED THE AREA TO SWELL AND REDNESS THAT PRODUCED A PURULENT DISCHARGE. IT WAS ALSO NOTED THAT THE PATIENT TO EXPERIENCED PAIN. THE PATIENT WAS PROVIDED WITH BACTRIM AND HAD RECOVERED. THE DEVICE REMAINS IMPLANTED AND IN SERVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT THAT THE PHYSICIAN BELIEVES THAT THE INFECTION WAS NOT DEVICE RELATED.
IT WAS REPORTED THAT FOLLOWING THE PERMANENT IMPLANT PROCEDURE THE PATIENT HAD WOUND DEHISCENCE AND DEVELOPED AN INFECTION AT THE POCKET AND INCISION SITE IN WHICH CAUSED THE AREA TO SWELL AND REDNESS THAT PRODUCED A PURULENT DISCHARGE. IT WAS ALSO NOTED THAT THE PATIENT TO EXPERIENCED PAIN. THE PATIENT WAS PROVIDED WITH BACTRIM AND HAD RECOVERED. THE DEVICE REMAINS IMPLANTED AND IN SERVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN BELIEVES THAT THE INFECTION WAS NOT DEVICE RELATED
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 365964 | WAVEWRITER ALPHA? 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1216 | 790479 | 08714729985082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Female | Required Intervention |