PATCH
Received Jul 6, 2012 · Event occurred May 29, 2012
Report 2124215-2012-07802 · MDR key 2643544
Device
Product problems
- Failure to Capture
- Low impedance
Patient
55 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EXPLANT PROCEDURE STATING THAT TESTING WITH HIGH AND LOW VOLTAGE SHOCKS RESULTED IN RUINING THE EXISTING LEADS. THEREFORE, THE PHYSICIAN ELECTED TO IMPLANT A SINGLE CHAMBER DEVICE.
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD WAS EXHIBITING IMPEDANCE MEASUREMENTS LESS THAN 200 OHMS AND NO CAPTURE DESPITE MAXIMUM DEVICE OUTPUTS. THE LEAD WAS SURGICALLY ABANDONED DURING AN ELECTIVE DEVICE REPLACEMENT PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Additional Manufacturer Narrative
THE LEAD WAS NOT RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.