FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 14177588
·
Received April 21, 2022
Report
- Report Number
- 3006630150-2022-01785
- Event Type
- Injury
- Date Received
- April 21, 2022
- Date of Event
- December 11, 2019
- Report Date
- April 21, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8336500, MODEL: SC-8336-50, SERIAL: (B)(4), BATCH: 7021410.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN WHICH WAS DESCRIBED AS BURNING THAT WAS NOT ALLEVIATED WITH THE SPINAL CORD STIMULATOR. IT WAS ALSO STATED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG AND PADDLE LEAD WERE EXPLANTED. THE EXPLANTED IPG AND LEAD WILL NOT BE RETURNED AS THEY WERE DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2004190 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 339492 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Female | Required Intervention |