UNKNOWN
Received Jan 10, 2013 · Event occurred Oct 11, 2012
Report 2124215-2012-14582 · MDR key 2908402
Device
Product problems
- High impedance
Patient
73 YR
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION IS EXPECTED WITH REGARD TO THIS ISSUE. THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ADAPTOR IS PART OF AN IMPLANTED SYSTEM THAT EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT ONE DAY AFTER IMPLANT. THE NEW ICD (MODEL/SERIAL F161/(B)(4)) WAS IMPLANTED WITH TWO EPICARDIAL TACHYCARDIA LEADS (MODEL/SERIAL 0041/(B)(4) AND 0041/(B)(4)) WITH AN ADAPTOR FOR EACH (THIS ADAPTOR AND MODEL/SERIAL 4312/(B)(4)). THE CAUSE OF THE HIGH SHOCK IMPEDANCE MEASUREMENT WAS NOT UNKNOWN. A REVISION PROCEDURE WAS SCHEDULED AND THE PATIENT WAS HOSPITALIZED.