FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 17863112
·
Received October 3, 2023
Report
- Report Number
- 3006630150-2023-05997
- Event Type
- Injury
- Date Received
- October 3, 2023
- Date of Event
- September 13, 2023
- Report Date
- October 3, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED ABOUT A YEAR AGO. BLOCK D6B: EXPLANT DATE: A YEAR AGO. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL:SC-2317-70. SERIAL: (B)(6). BATCH: 5146760/7072699.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT A FULL SYSTEM EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEADS WILL NOT BE RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 413829 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 353391 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Female | Required Intervention |