WAVEWRITER ALPHA?
Report
- Report Number
- 3006630150-2026-00166
- Event Type
- Injury
- Date Received
- January 7, 2026
- Date of Event
- December 11, 2025
- Report Date
- March 26, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE SC-1232; (B)(6) WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A LABELING REVIEW DID NOT REVEAL ANY ANOMALIES AS IT STATES THAT SYSTEM FAILURE, WHICH CAN OCCUR AT ANY TIME DUE TO RANDOM FAILURE(S) OF THE COMPONENTS OR THE BATTERY. THESE EVENTS, WHICH MAY INCLUDE DEVICE FAILURE, LEAD BREAKAGE, HARDWARE MALFUNCTIONS, LOOSE CONNECTIONS, ELECTRICAL SHORTS OR OPEN CIRCUITS AND LEAD INSULATION BREACHES, CAN RESULT IN INEFFECTIVE PAIN CONTROL AND THAT UNDESIRABLE STIMULATION MAY OCCUR OVER TIME DUE TO CELLULAR CHANGES IN TISSUE AROUND THE ELECTRODES, CHANGES IN ELECTRODE POSITION, LOOSE ELECTRICAL CONNECTIONS AND/OR LEAD FAILURE, ARE KNOWN RISKS OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION (SCS). BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF: KNOWN INHERENT RISK OF DEVICE THE DEVICES SC-2218-50; (B)(6) AND SC-2218-50; (B)(6) WERE NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A LABELING REVIEW DID NOT REVEAL ANY ANOMALIES AS IT STATES THAT UNDESIRABLE STIMULATION MAY OCCUR OVER TIME DUE TO CELLULAR CHANGES IN TISSUE AROUND THE ELECTRODES, CHANGES IN ELECTRODE POSITION, LOOSE ELECTRICAL CONNECTIONS AND/OR LEAD FAILURE IS A KNOWN RISK OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION (SCS). BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF: KNOWN INHERENT RISK OF DEVICE. B3: 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)(6), BATCH: 7145935, UDI: (B)(4), PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7151177, UDI: (B)(4).
B3: 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)(6), BATCH: 7145935, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7151177, UDI: (B)(4).
IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS DUE TO INADEQUATE STIMULATION. THE DEVICES WERE DISCARDED BY THE FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT PRESENTED NO ISSUES.
IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS DUE TO INADEQUATE STIMULATION. THE DEVICES WERE DISCARDED BY THE FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT PRESENTED NO ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59346 | WAVEWRITER ALPHA? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1232 | 767790 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Female | Required Intervention |