FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 9638475
·
Received January 28, 2020
Report
- Report Number
- 3006630150-2020-00225
- Event Type
- Injury
- Date Received
- January 28, 2020
- Date of Event
- December 19, 2019
- Report Date
- January 28, 2020
- 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
Narratives
Additional Manufacturer Narrative · 1
MODEL NUMBER/CATALOG NUMBER:SC-8336-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7062981, MODEL/CATALOG DESCRIPTION:COVERAGE 32 SURGICAL LEAD KIT 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG AND LEAD REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATE TO THE EVENT OCCURRED DURING MANUFACTURING.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED SIGNIFICANT CHANGES IN STIMULATION WITH CHANGES IN POSTURE. IT WAS ALSO NOTED THAT THE POCKET SITE WAS TENDER AND WARM TO TOUCHED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO PHYSICIAN SUSPECTED AN INFECTION BUT WAS LATER CONFIRMED THAT THERE WAS NO INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 100799 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 360333 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |