FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 3813388
·
Received May 15, 2014
Report
- Report Number
- 3006630150-2014-01065
- Event Type
- Injury
- Date Received
- May 15, 2014
- Date of Event
- April 18, 2014
- Report Date
- April 18, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- 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: MODEL #: SC-2218-50, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED EXTREME DISCOMFORT AT THE LEAD SITE DUE TO THE LEAD BOWING LATERALLY. X-RAY CONFIRMED LEAD MIGRATION. THE PATIENT UNDERWENT A REVISION PROCEDURE AND WAS REPORTEDLY DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290080 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention |