SPECTRA WAVEWRITER?
Report
- Report Number
- 3006630150-2026-01770
- Event Type
- Injury
- Date Received
- March 24, 2026
- Date of Event
- February 16, 2023
- Report Date
- May 15, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK B3: THE ESTIMATED EVENT DATE DERIVED FROM THE EXPLANT PROCEDURE OF DEVICES. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-70, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 5090352, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM, UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2218-70, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 5071830, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM, UNIQUE IDENTIFIER (UDI) #: (B)(4).
BLOCK B3: THE ESTIMATED EVENT DATE DERIVED FROM THE EXPLANT PROCEDURE OF DEVICES. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-70. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: (B)(6). MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2218-70. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: (B)(6). MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4).
THE DEVICES SC-1160, SERIAL NUMBER: (B)(6), SC-2218-70; SERIAL NUMBER: (B)(6) AND SC-2218-70; SERIAL NUMBER: (B)(6) WERE NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICES MET SPECIFICATION PRIOR TO SHIPPING. NO MANUFACTURING DEVIATIONS WERE NOTED THAT COULD HAVE CONTRIBUTED TO THE EVENT REPORTED. THERE IS NO COMPLAINT AGAINST THE FUNCTIONALITY OF THE DEVICES AND THE COMPLAINT AS REPORTED COULD NOT BE CONFIRMED. RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED. BLOCK B3: THE ESTIMATED EVENT DATE DERIVED FROM THE EXPLANT PROCEDURE OF DEVICES. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-70. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 5090352. MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2218-70. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 5071830. MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4).
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REPLACEMENT PROCEDURE OF THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS FOR AN UNSPECIFIED REASON. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS. FOLLOWING THE REPLACEMENT PROCEDURE, THE PATIENT FULLY RECOVERED.
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REPLACEMENT PROCEDURE OF THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS FOR AN UNSPECIFIED REASON. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS. FOLLOWING THE REPLACEMENT PROCEDURE, THE PATIENT FULLY RECOVERED.
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REPLACEMENT PROCEDURE OF THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS FOR AN UNSPECIFIED REASON. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS. FOLLOWING THE REPLACEMENT PROCEDURE, THE PATIENT FULLY RECOVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 275294 | SPECTRA WAVEWRITER? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1160 | 357288 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |