FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 3161893
·
Received June 11, 2013
Report
- Report Number
- 3006630150-2013-01185
- Event Type
- Injury
- Date Received
- June 11, 2013
- Date of Event
- May 15, 2013
- Report Date
- May 16, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT'S WHITE BLOOD CELL COUNTS WERE NORMAL AND THERE WAS NO SIGNS OF INFECTION PRESENT.
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50, SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT HAD INFECTION AND HAD BEEN TAKING MEDICATION FOR IT.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION WHICH WAS CONTAINED AND WAS NOT DEVICE RELATED. THE PATIENT HAD BEEN TAKING MEDICATION FOR IT.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION WHICH WAS CONTAINED AND WAS NOT DEVICE RELATED. THE PATIENT HAD BEEN TAKING MEDICATION FOR IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 263125 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |