InjuryNHW
PATCH
Received Jul 6, 2012 · Event occurred May 18, 2012
Report 2124215-2012-08888 · MDR key 2643513
Device
Product problems
- High impedance
Patient
68 YR
- No Consequences Or Impact To Patient
Narrative
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.
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE SYSTEM DISPLAYED A SHOCK IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS. A REVISION PROCEDURE WAS PERFORMED DUE TO THE ONGOING HIGH SHOCK IMPEDANCE ISSUE. THE ABDOMINALLY-PLACED DEVICE SYSTEM WAS REMOVED FROM SERVICE AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.