FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2842987
·
Received November 21, 2012
Report
- Report Number
- 3006630150-2012-02143
- Event Type
- Injury
- Date Received
- November 21, 2012
- Date of Event
- November 1, 2012
- Report Date
- November 1, 2012
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-70 SERIAL #: (B)(4), DESCRIPTION: ST LINEAR LEAD, 70CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT DURING AN IMPLANT PROCEDURE, THE PATIENT HAD PROFUSE BLEEDING FROM THE MIDLINE INCISION. THE PHYSICIAN REMOVED ALL THE IMPLANTED DEVICES AND STABILIZED THE PATIENT. THE PATIENT WAS REPORTEDLY DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Hospitalization| R |