FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 9050492
·
Received September 13, 2019
Report
- Report Number
- 3006630150-2019-05034
- Event Type
- Injury
- Date Received
- September 13, 2019
- Date of Event
- August 27, 2019
- Report Date
- September 13, 2019
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MODEL NUMBER / CATALOG NUMBER: SC-2317-70, SERIAL NUMBER: (B)(4), BATCH / LOT NUMBER: 20390212/2090212, MODEL / CATALOG DESCRIPTION: INFINION CX LEAD KIT 70 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW A SUPPLEMENTAL MED WATCH WILL BE FILED.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT EXPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 817214 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 20797127 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |