FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 15704858
·
Received October 31, 2022
Report
- Report Number
- 3006630150-2022-05876
- Event Type
- Injury
- Date Received
- October 31, 2022
- Date of Event
- May 27, 2020
- Report Date
- October 31, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED IN (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: 7072230/7072875.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DESPITE REPROGRAMMING ATTEMPTS. THE PATIENT UNDERWENT A SYSTEM EXPLANT PROCEDURE. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 461428 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 363736 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female | Required Intervention |