WAVEWRITER ALPHA
Report
- Report Number
- 3006630150-2022-00197
- Event Type
- Injury
- Date Received
- January 26, 2022
- Date of Event
- January 6, 2022
- Report Date
- April 21, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DATE OF EVENT: 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: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7100415 / 7098524.
IT WAS REPORTED THAT THE PATIENT DEVELOPED A STAPHYLOCOCCUS AUREUS INFECTION. IT WAS NOTED THAT THE PATIENT WAS ALLERGIC TO MOST ANTIBIOTICS AND HAD SEVERAL INFECTIONS BEFORE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEADS WERE NOT RETURNED BY THE MEDICAL FACILITY.
IT WAS REPORTED THAT THE PATIENT DEVELOPED A STAPHYLOCOCCUS AUREUS INFECTION. IT WAS NOTED THAT THE PATIENT WAS ALLERGIC TO MOST ANTIBIOTICS AND HAD SEVERAL INFECTIONS BEFORE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEADS WERE NOT RETURNED BY THE MEDICAL FACILITY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 830914 | WAVEWRITER ALPHA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1232 | 520262 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Female | Required Intervention |