WAVEWRITER ALPHA
Report
- Report Number
- 3006630150-2023-02178
- Event Type
- Injury
- Date Received
- April 21, 2023
- Date of Event
- March 27, 2023
- Report Date
- November 14, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- Adverse Event
- Yes
- Product Problem
- 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: 7080914 PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(6) LOT: 7080403 VISUAL INSPECTION OF THE RETURNED LEADS SC-2317-70 SN (B)(6) AND SN (B)(6) BOTH REVEALED THEY WERE CLEANLY CUT INTO FOUR PIECES NEAR THE DISTAL END OF THE LEADS. THE CLEAN-CUT DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE. NO OTHER ANOMALIES WERE IDENTIFIED ASIDE FROM THE CLEAN CUT. THE RETURNED IPG WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICES WERE 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)(4), LOT: 7080914. PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(4), LOT: 7080403.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). LOT: 7080914. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). LOT: 7080403. PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180. MODEL: SC-4318. SERIAL: N/A. LOT: 30959003. VISUAL INSPECTION OF THE RETURNED LEADS SC-2317-70 SN (B)(6) AND SN (B)(6) BOTH REVEALED THEY WERE CLEANLY CUT INTO FOUR PIECES NEAR THE DISTAL END OF THE LEADS. THE CLEAN-CUT DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE. NO OTHER ANOMALIES WERE IDENTIFIED ASIDE FROM THE CLEAN CUT. THE RETURNED IPG WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. EXTERNAL VISUAL INSPECTION OF THE CLIK ANCHOR SC-4318 LOT 30959003 DID NOT REVEAL ANY ANOMALIES. NO ANOMALIES WERE FOUND ON THE CLIK ANCHOR EYELETS. THE CLIK ANCHOR WAS TESTED WITH RELATED LEADS AND THE CLIK ANCHOR SET SCREW WAS TIGHTENED AND LOOSENED ON THE LEAD BODIES WITHOUT ANY ANOMALY. THE CLIK ANCHOR WAS ABLE TO SECURE THE LEADS APPROPRIATELY. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICES WERE 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: (B)(6). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), LOT: (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: 7080914. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700 MODEL: SC-2317-70. SERIAL: (B)(6). LOT: 7080403.
IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT EXPERIENCED MILD POSTPROCEDURAL COMPLICATIONS OF A SUSPECTED INFECTION OF THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD SITES. THE PATIENT WAS ADMINISTERED MEDICATION AND THE DEVICE WAS REPROGRAMMED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFECTED WOUND AREA WAS DEBRIDED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFECTION PERSISTED AT THE THORACIC INCISION AS OPPOSED TO THE POCKET INCISION. THE PATIENT UNDERWENT A SYSTEM EXPLANT PROCEDURE AND THE EVENT HAS RESOLVED.
IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT EXPERIENCED MILD POSTPROCEDURAL COMPLICATIONS OF A SUSPECTED INFECTION OF THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD SITES. THE PATIENT WAS ADMINISTERED MEDICATION AND THE DEVICE WAS REPROGRAMMED. THE DEVICE REMAINS IMPLANTED IN THE PATIENT.
IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT EXPERIENCED MILD POSTPROCEDURAL COMPLICATIONS OF A SUSPECTED INFECTION OF THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD SITES. THE PATIENT WAS ADMINISTERED MEDICATION AND THE DEVICE WAS REPROGRAMMED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFECTED WOUND AREA WAS DEBRIDED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFECTION PERSISTED AT THE THORACIC INCISION AS OPPOSED TO THE POCKET INCISION. THE PATIENT UNDERWENT A SYSTEM EXPLANT PROCEDURE AND THE EVENT HAS RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE DAY THE PATIENT WAS SCHEDULED FOR THE WOUND CLEANING, IT ULTIMATELY TURNED INTO AN EXPLANT SURGERY DUE TO INABILITY TO ACCESS THE AREA. IT WAS DURING THIS PROCEDURE THAT THE PHYSICIAN FOUND THE LEAD ANCHOR WAS DETACHED AND SUPERFICIAL. THE PHYSICIAN STATED THAT THE CLIK ANCHOR USED TO SECURE THE LEAD COULD HAVE CONTRIBUTED TO THE INFECTION.
IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT EXPERIENCED MILD POSTPROCEDURAL COMPLICATIONS OF A SUSPECTED INFECTION OF THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD SITES. THE PATIENT WAS ADMINISTERED MEDICATION AND THE DEVICE WAS REPROGRAMMED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFECTED WOUND AREA WAS DEBRIDED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFECTION PERSISTED AT THE THORACIC INCISION AS OPPOSED TO THE POCKET INCISION. THE PATIENT THEN UNDERWENT A SYSTEM EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EVENT WAS ASSESSED TO BE RELATED TO THE PROCEDURE AND DEVICES.
IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT EXPERIENCED MILD POSTPROCEDURAL COMPLICATIONS OF A SUSPECTED INFECTION OF THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD SITES. THE PATIENT WAS ADMINISTERED MEDICATION AND THE DEVICE WAS REPROGRAMMED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFECTED WOUND AREA WAS DEBRIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 447381 | WAVEWRITER ALPHA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1232 | 562180 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Male | Required Intervention |