FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 3200502
·
Received July 1, 2013
Report
- Report Number
- 3006630150-2013-01350
- Event Type
- Injury
- Date Received
- July 1, 2013
- Date of Event
- June 11, 2013
- Report Date
- June 11, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2138-50, SERIAL #: (B)(4), DESCRIPTION: SCS 50 CM III LEAD; MODEL #: SC-2138-70, SERIAL #: (B)(4), DESCRIPTION: SCS 70 CM III LEAD.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT DUE TO SKIN IRRITATION FROM THE SUTURE. THE STITCHES WERE OPENING UP. ONE SUTURE WAS LOOSE AND THE PHYSICIAN SUTURED IT. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299348 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Required Intervention |