FDA Adverse Event
Injury
Summary report: N
COVEREDGE 32
MDR report key: 10123526
·
Received June 5, 2020
Report
- Report Number
- 3006630150-2020-02354
- Event Type
- Injury
- Date Received
- June 5, 2020
- Date of Event
- April 29, 2020
- Report Date
- June 5, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729832676
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R, UPN: (B)(4), MODEL: SC-1132, SERIAL: (B)(4), BATCH: 203315.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION DUE TO IMPAIRED WOUND HEALING. IT WAS THE WOUND FROM THE CERVICAL PADDLE THAT WAS PLACED AT THE BASE OF THE NECK. CULTURES WERE TAKEN AND CT SCAN WAS PERFORMED AND THE RESULTS WERE NEGATIVE AND NORMAL, RESPECTIVELY. PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE RELATED BUT RATHER RELATED TO OTHER MEDICAL CONDITIONS SINCE PATIENT WAS DIAGNOSED WITH CANCER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 587098 | COVEREDGE 32 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-8336-70 | 19397773 | 08714729832676 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Required Intervention |