FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA
MDR report key: 19678785
·
Received July 5, 2024
Report
- Report Number
- 3006630150-2024-04332
- Event Type
- Injury
- Date Received
- July 5, 2024
- Date of Event
- March 3, 2023
- Report Date
- July 5, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
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-LINEAR LEADS UPN: M365SC2317700, MODEL: SC-2317-70 , SERIAL: (B)(6), BATCH: 7080854/7080877.
Description of Event or Problem · 0
IT WAS REPORTED THAT PATIENT EXPERIENCED A PAIN, NEEDLE LIKE STIMULATION IN THE LEFT SIDE, AND INADEQUATE STIMULATION. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED PER HOSPITAL POLICY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 473988 | WAVEWRITER ALPHA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1232 | 558621 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Female | Required Intervention |