FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 10901067
·
Received November 25, 2020
Report
- Report Number
- 3006630150-2020-05801
- Event Type
- Injury
- Date Received
- November 25, 2020
- Date of Event
- September 1, 2020
- Report Date
- November 24, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2020. EXPLANT DATE: (B)(6) 2020. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7070610. PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: (B)(4), MODEL: SC-8216-70, SERIAL: (B)(4), BATCH: 7070126. PRODUCT FAMILY: SCS-ADAPTERS, UPN: (B)(4), MODEL: SC-9218-15, SERIAL: (B)(4), BATCH: 7007666.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. ALL COMPONENTS WERE EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1364702 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 352332 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |