FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 18108558
·
Received November 10, 2023
Report
- Report Number
- 3006630150-2023-06911
- Event Type
- Injury
- Date Received
- November 10, 2023
- Date of Event
- October 6, 2022
- Report Date
- November 10, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED A YEAR AGO FROM THE DATE THE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7080208/7082371.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INCREASED PAIN NOT CONTROLLED BY THE DEVICE DESPITE MULTIPLE REPROGRAMMING ATTEMPTS. NO DEVICE MALFUNCTION WAS SUSPECTED. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED PER HOSPITAL POLICY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1832643 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 374026 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Male | Required Intervention |