FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA PRIME 16
MDR report key: 16795404
·
Received April 24, 2023
Report
- Report Number
- 3006630150-2023-02229
- Event Type
- Injury
- Date Received
- April 24, 2023
- Date of Event
- June 7, 2021
- Report Date
- May 12, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729985068
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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: 7092852/7092906.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD SYSTEM EXPLANT PROCEDURE. THE EXPLANTED DEVICES WILL NOT BE RETURNED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1936617 | WAVEWRITER ALPHA PRIME 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1416 | 201431 | 08714729985068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Male | Required Intervention |