WAVEWRITER ALPHA?
Report
- Report Number
- 3006630150-2025-02607
- Event Type
- Injury
- Date Received
- April 18, 2025
- Date of Event
- July 26, 2024
- Report Date
- May 22, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK B3: APPROXIMATED BASED ON THE DATE THE EXPLANT DATE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138250. MODEL: SC-3138-25. SERIAL: (B)(6). BATCH: 7073311. PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138250. MODEL: SC-3138-25. SERIAL: (B)(6). BATCH: 7073320. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI. UPN: M365SC2408740. MODEL: SC-2408-74. SERIAL: (B)(6). BATCH: 7078263. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI. UPN: M365SC2408740. MODEL: SC-2408-74. SERIAL: (B)(6). BATCH: 7078392. PRODUCT FAMILY: SCS-LEAD FIXATION-MRI. UPN: M365SC43190. MODEL: SC-4319. SERIAL: N/A. BATCH: 32546212.
BLOCK 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-EXTENSION UPN: M365SC3138250 MODEL: SC-3138-25 SERIAL: (B)(6). BATCH: (B)(6). PRODUCT FAMILY: SCS-EXTENSION UPN: M365SC3138250 MODEL: SC-3138-25 SERIAL: (B)(6). BATCH: (B)(6). PRODUCT FAMILY: SCS-LINEAR LEADS-MRI UPN: M365SC2408740 MODEL: SC-2408-74 SERIAL: (B)(6). BATCH: (B)(6). PRODUCT FAMILY: SCS-LINEAR LEADS-MRI UPN: M365SC2408740 MODEL: SC-2408-74 SERIAL: (B)(6). BATCH: (B)(6). PRODUCT FAMILY: SCS-LEAD FIXATION-MRI UPN: M365SC43190 MODEL: SC-4319 SERIAL: N/A BATCH: 32546212.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE WHICH STARTED AT THE SPINAL CORD STIMULATION (SCS) LEAD ANCHOR FIXATION SITE AND PASSED THROUGH THE TUNNEL AND SPREAD TO THE IPG SITE. THE PATIENT SYMPTOMS INCLUDED PAIN AT THE INFECTED SITE. THE PHYSICIAN ASSESSED THAT THE INFECTION WAS DEVICE RELATED, HOWEVER, ALSO ASSESSED THAT NOTHING HAPPENED DURING THE SCS PROCEDURE THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE INFECTION. A CULTURE WAS TAKEN AND CONFIRMED METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). DUE TO RENAL FAILURE, STRONG MEDICATION WAS AVOIDED, BUT VANCOMYCIN WAS ADMINISTERED. THE PATIENT UNDERWENT A PROCEDURE WHERE THE SCS SYSTEM WAS EXPLANTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE WOUND WAS OPENED, DISINFECTED EVERY WEEK AT THE OUTPATIENT CLINIC, AND THEN CLOSED.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE WHICH STARTED AT THE SPINAL CORD STIMULATION (SCS) LEAD ANCHOR FIXATION SITE AND PASSED THROUGH THE TUNNEL AND SPREAD TO THE IPG SITE. THE PATIENT SYMPTOMS INCLUDED PAIN AT THE INFECTED SITE. THE PHYSICIAN ASSESSED THAT THE INFECTION WAS DEVICE RELATED, HOWEVER, ALSO ASSESSED THAT NOTHING HAPPENED DURING THE SCS PROCEDURE THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE INFECTION. A CULTURE WAS TAKEN AND CONFIRMED METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). DUE TO RENAL FAILURE, STRONG MEDICATION WAS AVOIDED, BUT VANCOMYCIN WAS ADMINISTERED. THE PATIENT UNDERWENT A PROCEDURE WHERE THE SCS SYSTEM WAS EXPLANTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 32273 | WAVEWRITER ALPHA? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1232 | 596437 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Female | Required Intervention |