WAVEWRITER ALPHA?
Report
- Report Number
- 3006630150-2025-06847
- Event Type
- Injury
- Date Received
- August 25, 2025
- Date of Event
- July 19, 2025
- Report Date
- April 23, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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: M365SC2352700. MODEL: SC-2352-70. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2352700. MODEL: SC-2352-70. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4).
B3: ESTIMATED BASED ON GFE RESPONSE FROM SALES REPRESENTATIVE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 7081620, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 7081626, UDI: (B)(4).
B3: ESTIMATED BASED ON GFE RESPONSE FROM SALES REPRESENTATIVE ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2352700 MODEL: SC-2352-70 SERIAL: (B)(6). BATCH: 7081620 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2352700 MODEL: SC-2352-70 SERIAL: (B)(6) BATCH: 7081626 UDI: (B)(4).
IT WAS REPORTED THAT THESE SPINAL CORD STIMULATION (SCS) DEVICES WERE EXPLANTED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THESE SPINAL CORD STIMULATION (SCS) DEVICES WERE EXPLANTED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THIS SCS PATIENT UNDERWENT THE EXPLANT PROCEDURE DUE TO AN INFECTION THAT WAS INITIALLY LOCALIZED AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE, WHICH SUBSEQUENTLY PROGRESSED TO THE LEADS SITE AND EXTENDED TO THE CERVICAL SCAR. THE PRIMARY SYMPTOM WAS WOUND DRAINAGE ACCOMPANIED BY THE ONSET OF DEHISCING. THE PATIENT WAS SUBSEQUENTLY STARTED ON ANTIBIOTICS. THE PRECISE CAUSE OF THE INFECTION REMAINS UNDETERMINED; ALTHOUGH CULTURES WERE OBTAINED, THE RESULTS ARE NOT ACCESSIBLE. POSTOPERATIVELY, THE PATIENT WAS DOING WELL. THE DEVICES WERE RETAINED DUE TO HOSPITAL POLICY AND WILL NOT BE RETURNED FOR ANALYSIS.
IT WAS REPORTED THAT THESE SPINAL CORD STIMULATION (SCS) DEVICES WERE EXPLANTED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THIS SCS PATIENT UNDERWENT THE EXPLANT PROCEDURE DUE TO AN INFECTION THAT WAS INITIALLY LOCALIZED AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE, WHICH SUBSEQUENTLY PROGRESSED TO THE LEADS SITE AND EXTENDED TO THE CERVICAL SCAR. THE PRIMARY SYMPTOM WAS WOUND DRAINAGE ACCOMPANIED BY THE ONSET OF DEHISCING. THE PATIENT WAS SUBSEQUENTLY STARTED ON ANTIBIOTICS. THE PRECISE CAUSE OF THE INFECTION REMAINS UNDETERMINED; ALTHOUGH CULTURES WERE OBTAINED, THE RESULTS ARE NOT ACCESSIBLE. POSTOPERATIVELY, THE PATIENT WAS DOING WELL. THE DEVICES WERE RETAINED DUE TO HOSPITAL POLICY AND WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE IPG HAS BEEN RETURNED AND WILL UNDERGO ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 218448 | WAVEWRITER ALPHA? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1232 | 594167 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |