PRECISION
Report
- Report Number
- 3006630150-2011-00273
- Event Type
- Injury
- Date Received
- February 25, 2011
- Date of Event
- January 31, 2011
- Report Date
- January 31, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- NURSE
Narratives
THE PATIENT HAD SUREGERY AND ALL ITEMS WERE REPLACED AND DISCARDED.
ADDITIONAL INFORMATION REVEALED THAT THE PATIENT'S REVISION SURGERY HAS BEEN CANCELLED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.
A REPORT WAS RECEIVED THAT A PATIENT'S LEFT LEAD WAS EXHIBITING HIGH IMPEDANCES. THE PHYSICIAN INDICATED THAT THE IPG IS THE CAUSE OF PROBLEM. A DATABASE ANALYSIS WAS PERFORMED BY A BSN ENGINEER WHICH SHOWED OPEN IMPEDANCES. THE PHYSICIAN IS RECOMMENDING A REVISION SURGERY.
A REPORT WAS RECEIVED THAT A PATIENT'S LEFT LEAD WAS EXHIBITING HIGH IMPEDANCES. THE PHYSICIAN INDICATED THAT THE IPG IS THE CAUSE OF PROBLEM. A DATABASE ANALYSIS WAS PERFORMED BY A BSN ENGINEER WHICH SHOWED OPEN IMPEDANCES. THE PHYSICIAN IS RECOMMENDING A REVISION SURGERY.
A REPORT WAS RECEIVED THAT A PT'S LEFT LEAD WAS EXHIBITING HIGH IMPEDANCES. THE PHYSICIAN INDICATED THAT THE IPG IS THE CAUSE OF PROBLEM. A DATABASE ANALYSIS WAS PERFORMED BY A BSN ENGINEER WHICH SHOWED OPEN IMPEDANCES. THE PHYSICIAN IS RECOMMENDING A REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention | (B)(4)| MODEL# SC-2208-50, (B)(4)| ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.012" STYLET |