PATCH
Received Jan 10, 2013 · Event occurred Oct 11, 2012
Report 2124215-2012-14580 · MDR key 2908279
Device
Product problems
- Fracture
- 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
FIELD FOLLOW-UP CONFIRMED A FRACTURED LEAD COMPONENT. DURING SURGICAL INTERVENTION, THE LEAD WAS REMOVED FROM SERVICE AND ANOTHER BOSTON SCIENTIFIC RIGHT VENTRICULAR LEAD IMPLANTED. NO RESULTING ADVERSE PATIENT EFFECTS WERE REPORTED.
Additional Manufacturer Narrative
NO RETURN OF PRODUCT IS EXPECTED. 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 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 F161/(B)(4)) WAS IMPLANTED WITH ANOTHER EPICARDIAL TACHYCARDIA LEAD (MODEL/SERIAL 0041/(B)(4)) WITH AN ADAPTOR FOR EACH LEAD (MODEL/SERIAL 4312/(B)(4) AND 4312/(B)(4)). THE CAUSE OF THE HIGH SHOCK IMPEDANCE MEASUREMENT WAS NOT UNKNOWN. A REVISION PROCEDURE WAS SCHEDULED AND THE PATIENT WAS HOSPITALIZED.