FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER?
MDR report key: 22117385
·
Received May 30, 2025
Report
- Report Number
- 3006630150-2025-03811
- Event Type
- Injury
- Date Received
- May 30, 2025
- Date of Event
- February 5, 2025
- Report Date
- May 30, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, 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: 7071645. UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7071762. UDI: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING FREQUENT IMPLANTABLE PULSE GENERATOR (IPG) CHARGING AND ONE OF THE PATIENTS LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT AN IPG AND LEAD REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED IPG AND LEAD WILL NOT BE RETURNED BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 773226 | SPECTRA WAVEWRITER? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1160 | 369079 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Male | Required Intervention |