MalfunctionNHW
PATCH
Received Oct 19, 2010 · Event occurred Nov 22, 2008
Report 2124215-2010-17758 · MDR key 1874806
Device
Product problems
- High impedance
Patient
67 YR
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
AS OF TODAY, THIS PRODUCT REMAINS IN-SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PRODUCT WAS EXHIBITING INTERMITTENT OUT OF RANGE SHOCKING LEAD IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS FOLLOWED BY NORMAL MEASUREMENTS. IT WAS STATED THAT THE PATIENT WAS TOO SICK TO PERFORM ADDITIONAL EVALUATION AND THE PHYSICIAN PLANS TO MONITOR THE PATIENT AT THIS TIME. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. AT THIS TIME, THE CAUSE OF THE OUT OF RANGE IMPEDANCE MEASUREMENTS IS UNKNOWN.