FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA
MDR report key: 16950783
·
Received May 17, 2023
Report
- Report Number
- 3006630150-2023-02807
- Event Type
- Injury
- Date Received
- May 17, 2023
- Date of Event
- November 29, 2022
- Report Date
- May 17, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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: SC-2317-70, MODEL: M365SC2317700, SERIAL: (B)(4) AND BATCH: 7075037/7072523.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT COULD NOT FEEL THE PARESTHESIA AND WAS EXPERIENCING INADEQUATE PAIN RELIEF. THE PATIENT WAS REPROGRAMMED HOWEVER, IT DID NOT SOLVE THE ISSUE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN EVERYTHING WAS EXPLANTED AND WERE NOT RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1894094 | WAVEWRITER ALPHA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1232 | 515397 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male | Required Intervention |