FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 10273797
·
Received July 14, 2020
Report
- Report Number
- 3006630150-2020-02908
- Event Type
- Injury
- Date Received
- July 14, 2020
- Date of Event
- June 3, 2020
- Report Date
- July 14, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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: (B)(4), MODEL: SC 2218 50, SERIAL: (B)(4), BATCH: 5171607/ 7074328.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS HAVING PAIN AT THE BATTERY SITE DUE TO PLACEMENT AND WAS GETTING INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 735838 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 365215 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention |