FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 17300009
·
Received July 11, 2023
Report
- Report Number
- 3006630150-2023-04030
- Event Type
- Injury
- Date Received
- July 11, 2023
- Date of Event
- May 31, 2019
- Report Date
- July 11, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 5081784.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE STIMULATION COVERAGE DESPITE REPROGRAMMING DONE. IT WAS ALSO NOTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG POCKET SITE. HIGH IMPEDANCE WAS ALSO OBSERVED IN THE LEAD. THE PATIENT UNDERWENT AN IPG AND LEAD REPLACEMENT PROCEDURE. THE EXPLANTED IPG AND LEAD WERE DISCARDED BY THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2193728 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 353904 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male | Required Intervention |