FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA PRIME 16
MDR report key: 17311192
·
Received July 12, 2023
Report
- Report Number
- 3006630150-2023-04062
- Event Type
- Injury
- Date Received
- July 12, 2023
- Date of Event
- June 1, 2023
- Report Date
- March 7, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729985068
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED THREE WEEKS AGO.
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(6); BATCH: 7120581/7120579.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT DEVELOPED A SEROMA. THE PHYSICIAN DRAINED THE IPG INCISION SITE. THE PATIENT WAS PLACED ON BACTRIM ANTIBIOTIC.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT DEVELOPED A SEROMA. THE PHYSICIAN DRAINED THE IPG INCISION SITE. THE PATIENT WAS PLACED ON BACTRIM ANTIBIOTIC. ADDITIONAL INFORMATION WAS RECEIVED THAT ALL DEVICE COMPONENTS WERE EXPLANTED DUE TO INFECTION. NO FURTHER INFORMATION HAS BEEN OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 233662 | WAVEWRITER ALPHA PRIME 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1416 | 212991 | 08714729985068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Male | Required Intervention |