FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA
MDR report key: 18070213
·
Received November 4, 2023
Report
- Report Number
- 3006630150-2023-06773
- Event Type
- Injury
- Date Received
- November 4, 2023
- Date of Event
- September 22, 2022
- Report Date
- November 3, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, 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: 7113447/7071574/7074444.
Description of Event or Problem · 0
IT WAS REPORTED THAT FOLLOWING A LEAD REVISION PROCEDURE (MFR NUMBER 3006630150-2023-04456), THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG AND LEADS WERE EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1952139 | WAVEWRITER ALPHA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1232 | 514601 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Female | Required Intervention |