PATCH
Received Jul 8, 2013 · Event occurred Apr 5, 2013
Report 2124215-2013-06148 · MDR key 3209637
Device
Product problems
- High impedance
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, WHEN THE CHRONIC RIGHT VENTRICULAR LEAD WAS CONNECTED WITH AN ADAPTOR TO THIS DEVICE HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WERE OBTAINED. MEASUREMENTS WITH THE PREVIOUS DEVICE (VENTAK PRISM MODEL 1857) WERE WITHIN NORMAL RANGE. CONNECTIONS WERE VERIFIED. IN ADDITION, THE DIFFERENT VECTORS WERE MEASURED AND DISPLAYED SIMILAR OUT OF RANGE MEASUREMENTS. ELECTROGRAMS WERE NORMAL. THE PROCEDURE WAS ENDED WITHOUT A SHOCK DELIVERY AND FURTHER FOLLOW UP WILL BE PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS OBTAINED. A 1.1 JOULE SHOCK WAS DELIVER. SUBSEQUENTLY, A REPLACEMENT PROCEDURE WAS PERFORMED. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED.
Additional Manufacturer Narrative
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.