FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA?
MDR report key: 22023086
·
Received May 14, 2025
Report
- Report Number
- 3006630150-2025-03342
- Event Type
- Injury
- Date Received
- May 14, 2025
- Date of Event
- March 7, 2025
- Report Date
- May 14, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, 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 COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7082297, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7080668, UDI: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT PATIENT WAS NOT ABLE TO GET ENOUGH PAIN RELIEF FROM THE SPINAL CORD STIMULATOR (SCS) DEVICE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE WHERE IN ALL DEVICES WERE REMOVED. THE EXPLANTED DEVICE WILL NOT BE RETURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1880402 | WAVEWRITER ALPHA? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1232 | 567532 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Male | Required Intervention |