FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 16857067
·
Received May 2, 2023
Report
- Report Number
- 3006630150-2023-02439
- Event Type
- Injury
- Date Received
- May 2, 2023
- Date of Event
- October 9, 2019
- Report Date
- May 2, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- 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: 5106569. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 5071930.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE SPINAL CORD SYSTEM (SCS) WAS REMOVED. THE EXPLANTED DEVICES WERE DISPOSED OF BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2321974 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 356012 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Male | Required Intervention |