FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 11672586
·
Received April 15, 2021
Report
- Report Number
- 3006630150-2021-01594
- Event Type
- Injury
- Date Received
- April 15, 2021
- Date of Event
- May 1, 2020
- Report Date
- April 15, 2021
- 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
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED IN THE ESTIMATE OF (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: 5150325/5160291.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE COVERAGE. THE PATIENT UNDERWENT A FULL SPINAL CORD SYSTEM (SCS) REPLACEMENT PROCEDURE. THE EXPLANTED IPG AND LEADS WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 569181 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 356181 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |