FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1901609
·
Received November 12, 2010
Report
- Report Number
- 3006630150-2010-01947
- Event Type
- Injury
- Date Received
- November 12, 2010
- Date of Event
- October 18, 2010
- Report Date
- October 18, 2010
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT'S ENTIRE SYSTEM WAS EXPLANTED DUE TO INFECTION. THE PATIENT'S SYMPTOMS WERE PAIN, FEVER, AND CHILLS. THE PATIENT WAS GIVEN ANTIBIOTICS AND THE PHYSICIAN BELIEVES THE INFECTION WAS DEVICE RELATED.
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 | 30 YR | Required Intervention | SERIAL # - (B)(4)| MODEL # - SC-8216-50| ARTISAN 2X8 PADDLE LEAD (LIM), 50 CM |