FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1914199
·
Received December 1, 2010
Report
- Report Number
- 3006630150-2010-02047
- Event Type
- Injury
- Date Received
- December 1, 2010
- Date of Event
- November 2, 2010
- Report Date
- November 2, 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
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN FOR ANALYSIS AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MFG DOCUMENTATION FOR THE EXPLANTED DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MFG. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE EXPLANTED DEVICES FOUND THEM TO BE SATISFACTORY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT A PT'S PRECISION SYSTEM WAS EXPLANTED DUE TO AN INFECTION AT THE LEAD SITE. THE PT HAD EXPERIENCED REDNESS AT THE LEAD SITE. THE PT RECEIVED IV ANTIBIOTICS AT THE TIME OF EXPLANT AND WAS PRESCRIBED ORAL ANTIBIOTICS FOLLOWING EXPLANT. THE PT WAS REPORTEDLY DOING WELL FOLLOWING THE EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention | ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014" STYLET| SN (B)(4)| IPG KIT WITHOUT PULL-THROUGH TUNNELER| MODEL # SC-2218-50, SERIAL # (B)(4)| MODEL # SC-1110-02, SERIAL # (B)(4) |