FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 3083355
·
Received April 29, 2013
Report
- Report Number
- 3006630150-2013-00831
- Event Type
- Injury
- Date Received
- April 29, 2013
- Date of Event
- April 8, 2013
- Report Date
- April 8, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT'S POCKET SITE WOUND HAD PUS BUT THE PHYSICIAN CONFIRMED THAT IT WAS NOT INFECTED. THE PHYSICIAN EXPLANTED THE PATIENT'S IPG DUE TO POOR WOUND HEALING AT THE POCKET SITE. THE PHYSICIAN BELIEVED THAT THE EVENT WAS A TYPICAL SIDE EFFECT AFTER THE SURGERY. THE PATIENT WAS REPORTEDLY DOING WELL AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 185548 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |