WAVEWRITER ALPHA
Report
- Report Number
- 3006630150-2024-01912
- Event Type
- Injury
- Date Received
- March 29, 2024
- Date of Event
- December 11, 2023
- Report Date
- February 27, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), LOT: 7082737. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), LOT: 7082902.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6); PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6).
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(6). LOT: (B)(6). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(6). LOT: (B)(6). PRODUCT FAMILY: SCS-LEAD FIXATION UPN: M365SC43180 MODEL: SC-4318 SERIAL: N/A LOT: 32497828.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). LOT: 7082737. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). LOT: 7082902. PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180. MODEL: SC-4318. SERIAL: N/A. LOT: 32497828. THE LEADS AND CLICK ANCHOR WERE NOT RETURNED BY THE MEDICAL FACILITY FOR ANALYSIS. THE RETURNED IPG WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) PRODUCT LABEL. PER THE IFU, POSSIBLE RISKS OF IMPLANTING A PULSE GENERATOR TO DELIVER SPINAL CORD STIMULATION INCLUDE PROCEDURAL RISKS SUCH AS TEMPORARY PAIN AT THE IMPLANT SITE AND INFECTION.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL:(B)(6) , LOT: 7082737 . PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6) , LOT: 7082902. PRODUCT FAMILY: SCS-LEAD FIXATION: UPN: M365SC43180, MODEL: SC-4318, SERIAL: N/A , LOT: 32497828. THE CLIK ANCHOR WAS NOT RETURNED BY THE MEDICAL FACILITY FOR ANALYSIS. THE RETURNED IPG WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) PRODUCT LABEL. PER THE IFU, POSSIBLE RISKS OF IMPLANTING A PULSE GENERATOR TO DELIVER SPINAL CORD STIMULATION INCLUDE PROCEDURAL RISKS SUCH AS TEMPORARY PAIN AT THE IMPLANT SITE AND INFECTION. THE RETURNED LEADS SC-2317-70, (B)(6) AND (B)(6) WERE ANALYZED AND REVEALED THAT THE LEADS WERE CLEANLY CUT. THIS DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IS NOT CONSIDERED A FAILURE. NO OTHER ANOMALIES WERE IDENTIFIED ON THE RETURNED PORTION OF THE LEADS. PER THE IFU, POSSIBLE RISKS OF IMPLANTING A PULSE GENERATOR SYSTEM TO DELIVER SPINAL CORD STIMULATION INCLUDE PROCEDURAL RISKS SUCH AS TEMPORARY PAIN AT THE IMPLANT SITE AND INFECTION.
IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT EXPERIENCED A RETURN AND WORSENING OF THE INFECTION AND PAIN AT THE THORACIC INCISION SITE (SEE MFR. REPORT 3006630150-2023-08561). THE PATIENT WAS ADMINISTERED ANTIBIOTICS. THE PHYSICIAN ASSESSED THE EVENT WAS DUE TO THE PROCEDURE AND IPG HARDWARE. ALL DEVICES REMAIN IMPLANTED IN THE PATIENT.
IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT EXPERIENCED A RETURN AND WORSENING OF THE INFECTION AND PAIN AT THE THORACIC INCISION SITE (SEE MFR. REPORT 3006630150-2023-08561). THE PATIENT WAS ADMINISTERED ANTIBIOTICS. THE PHYSICIAN ASSESSED THE EVENT WAS DUE TO THE PROCEDURE AND IPG HARDWARE. ALL DEVICES REMAIN IMPLANTED IN THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFECTION RETURNED.
IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT EXPERIENCED A RETURN AND WORSENING OF THE INFECTION AND PAIN AT THE THORACIC INCISION SITE (SEE MFR. REPORT 3006630150-2023-08561). THE PATIENT WAS ADMINISTERED ANTIBIOTICS. THE PHYSICIAN ASSESSED THE EVENT WAS DUE TO THE PROCEDURE AND IPG HARDWARE. ALL DEVICES REMAIN IMPLANTED IN THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFECTION RETURNED AND THE PATIENT UNDERWENT A SYSTEM EXPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LOCATION OF THE INFECTION AND SORENESS WERE NEAR THE THORACIC INCISIONAL SITE. THE DEVICES WERE NOT BELIEVED TO BE THE CAUSE OF THE INFECTION; HOWEVER, IT COULD NOT BE COMPLETELY RULED OUT. THE PATIENT WAS PRESCRIBED ANTIBIOTICS FOLLOWING THE EXPLANT PROCEDURE. THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY.
IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT EXPERIENCED A RETURN AND WORSENING OF THE INFECTION AND PAIN AT THE THORACIC INCISION SITE (SEE MFR. REPORT 3006630150-2023-08561). THE PATIENT WAS ADMINISTERED ANTIBIOTICS. THE PHYSICIAN ASSESSED THE EVENT WAS DUE TO THE PROCEDURE AND IPG HARDWARE. ALL DEVICES REMAIN IMPLANTED IN THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFECTION RETURNED AND THE PATIENT UNDERWENT A SYSTEM EXPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LOCATION OF THE INFECTION AND SORENESS WERE NEAR THE THORACIC INCISIONAL SITE. THE DEVICES WERE NOT BELIEVED TO BE THE CAUSE OF THE INFECTION; HOWEVER, IT COULD NOT BE COMPLETELY RULED OUT. THE PATIENT WAS PRESCRIBED ANTIBIOTICS FOLLOWING THE EXPLANT PROCEDURE. THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY.
IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT EXPERIENCED A RETURN AND WORSENING OF THE INFECTION AND PAIN AT THE THORACIC INCISION SITE (SEE MFR. REPORT 3006630150-2023-08561). THE PATIENT WAS ADMINISTERED ANTIBIOTICS. THE PHYSICIAN ASSESSED THE EVENT WAS DUE TO THE PROCEDURE AND IPG HARDWARE. ALL DEVICES REMAIN IMPLANTED IN THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFECTION RETURNED AND THE PATIENT UNDERWENT A SYSTEM EXPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LOCATION OF THE INFECTION AND SORENESS WERE NEAR THE THORACIC INCISIONAL SITE. THE DEVICES WERE NOT BELIEVED TO BE THE CAUSE OF THE INFECTION, HOWEVER, IT COULD NOT BE COMPLETELY RULED OUT. THE PATIENT WAS PRESCRIBED ANTIBIOTICS FOLLOWING THE EXPLANT PROCEDURE. THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2586876 | WAVEWRITER ALPHA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1232 | 568718 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Female | Required Intervention |