FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 11860686
·
Received May 20, 2021
Report
- Report Number
- 3006630150-2021-02280
- Event Type
- Injury
- Date Received
- May 20, 2021
- Date of Event
- February 16, 2021
- Report Date
- May 20, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: SCS-LINEAR LEADS. MODEL: SC-2218-50. SERIAL: (B)(4). BATCH: 5062332/5098294.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF AND DISCOMFORT WITH THE SPINAL CORD STIMULATOR (SCS) DEVICE. ALL DEVICE COMPONENTS WERE EXPLANTED AND WERE NOT RETURNED
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 751271 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 360804 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |