FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 9846347
·
Received March 18, 2020
Report
- Report Number
- 3006630150-2020-01247
- Event Type
- Injury
- Date Received
- March 18, 2020
- Date of Event
- November 6, 2019
- Report Date
- March 18, 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
MODEL NUMBER/CATALOG NUMBER: SC-2317-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5110937/5120706, MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. IT WAS ALSO NOTED THAT PATIENT HAD PAIN AT THE IPG SITE AND WAS NOT HAPPY ON HOW THE IPG STICKS OUT FROM THE BODY. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310215 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 352082 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |