FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 12589659
·
Received October 7, 2021
Report
- Report Number
- 3006630150-2021-05614
- Event Type
- Injury
- Date Received
- October 7, 2021
- Date of Event
- November 18, 2020
- Report Date
- October 7, 2021
- 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
Narratives
Additional Manufacturer Narrative · 1
EVENT DATE: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7080363/7080470.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS FEELING MORE PAIN AND WAS EXPERIENCING INADEQUATE STIMULATION. SYMPTOMS OF TINGLING AND NUMBNESS WERE NOTED. PATIENTS PAIN PERSISTED DESPITE REPROGRAMMING WHICH CAUSED UNDESIRED SENSATIONS. IT WAS ALSO NOTED THAT THE PATIENT WAS HAVING DISCOMFORT AT THE IPG SITE. ALL DEVICE COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1486939 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 372086 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Required Intervention |