PATCH
Received Jan 10, 2013 · Event occurred Oct 11, 2012
Report 2124215-2012-14579 · MDR key 2908298
Device
Product problems
- High impedance
Patient
73 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LARGE EPICARDIAL TACHYCARDIA PATCH IS PART OF AN IMPLANTED SYSTEM THAT EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT ONE DAY AFTER IMPLANT. THIS NEW ICD (MODEL/SERIAL (B)(4)) WAS IMPLANTED WITH ANOTHER EPICARDIAL TACHYCARDIA LEAD (MODEL/SERIAL 0041/(B)(4)) WITH AN ADAPTOR FOR EACH LEAD (MODEL/SERIAL (B)(4) AND (B)(4)). THE CAUSE OF THE HIGH SHOCK IMPEDANCE MEASUREMENT WAS NOT UNKNOWN. A REVISION PROCEDURE WAS SCHEDULED AND THE PATIENT WAS HOSPITALIZED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION IS EXPECTED WITH REGARD TO THIS ISSUE. THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.