FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2822962
·
Received November 7, 2012
Report
- Report Number
- 3006630150-2012-02034
- Event Type
- Injury
- Date Received
- November 7, 2012
- Date of Event
- October 15, 2012
- Report Date
- October 15, 2012
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL:SC-8216-50, SERIAL: (B)(4), DESCRIPTION:ARTISAN SURGICAL LEAD, 50CM MODEL:SC-4316, SERIAL: (B)(4), DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE. EXPLANTED IPG AND LEADS WILL NOT BE RETURNED TO BSN AS THEY WERE DISCARDED BY MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT HAD A FEVER AND A LUMP AT THE MIDLINE INCISION SITE. THE PATIENT WAS GIVEN ORAL AND INTRAVENOUS ANTIBIOTICS DUE TO INFECTION, WHICH THE PHYSICIAN BELIEVES WAS PROCEDURE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT IS REPORTEDLY DOING WELL AFTER THE PROCEDURE.
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 | 44 YR | Required Intervention |