PATCH
Received Jan 11, 2013 · Event occurred Nov 16, 2012
Report 2124215-2012-16480 · MDR key 2910803
Device
Product problems
- High impedance
- Appropriate Device Problem Term/Code Not Available
Patient
51 YR
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
THE LEADS REMAIN IMPLANTED AND SURGICALLY ABANDONED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT OUT OF RANGE SHOCK IMPEDANCES GREATER THAN 125 OHMS WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THIS WAS NOTED FOLLOWING THE RECENT DEVICE CHANGE OUT THAT OCCURRED IN THE PREVIOUS MONTH. THIS PATIENT HAS AN ABDOMINAL SYSTEM. THE CONCERN WAS THAT THIS MAY BE THE CAUSE OF THE OUT OF RANGE MEASUREMENTS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED PERFORMING FURTHER TESTING OR TO PERFORM A SAVE TO DISC FOR FURTHER INFORMATION. SUBSEQUENTLY ADDITIONAL INFORMATION WAS RECEIVED THAT FOUR DAYS FOLLOWING THIS REPORT, THIS SYSTEM WAS PART OF A REVISION DUE TO AN INFECTION. NO ADDITIONAL TESTING OR FOLLOW-UP WAS PERFORMED BECAUSE OF THE INFECTION. THERE WERE NO PATIENT SYMPTOMS OR ADVERSE EFFECTS RELATED TO THE OUT OF RANGE IMPEDANCE MEASUREMENTS. THE LEADS WERE ABANDONED AND REMAIN IMPLANTED. THE DEVICE WILL BE RETURNED.