FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 3232836
·
Received July 18, 2013
Report
- Report Number
- 3006630150-2013-01493
- Event Type
- Injury
- Date Received
- July 18, 2013
- Date of Event
- June 25, 2013
- Report Date
- June 25, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50E SERIAL #: (B)(4), DESCRIPTION: TRIAL LINEAR ST LEAD, 50CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE TRIAL PATIENT WAS BLEEDING A DAY AFTER BEING IMPLANTED. THE PATIENT UNDERWENT EARLY LEAD PULL AND WAS DOING WELL FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 333241 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50E | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |