FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 3180240
·
Received June 20, 2013
Report
- Report Number
- 3006630150-2013-01275
- Event Type
- Injury
- Date Received
- June 20, 2013
- Date of Event
- May 8, 2013
- Report Date
- May 8, 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 INFORMATION WAS RECEIVED THAT THE MIGRAINE WAS NOT DEVICE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE BECAUSE THE PATIENT NO LONGER NEEDED THE DEVICE. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2108-70M, SERIAL #: (B)(4), DESCRIPTION: SCS LEAD KIT, PHASE 2 STERILE PACKAGE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WOULD GET BAD MIGRAINES WHEN HE INCREASES HIS STIMULATION. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WOULD GET BAD MIGRAINES WHEN HE INCREASES HIS STIMULATION. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 279685 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |