PATCH
Received Jul 6, 2012 · Event occurred Apr 19, 2012
Report 2124215-2012-06000 · MDR key 2642009
Device
Product problems
- High impedance
Patient
40 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A RED ALERT WAS RECEIVED FROM THIS LEAD DUE TO A SHOCK IMPEDANCE GREATER THAN 125 OHMS. THRESHOLDS, SENSING AND IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL LIMITS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Additional Manufacturer Narrative
A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE REPORTED CLINICAL OBSERVATIONS AND STATED THE LEAD COULD BE FRACTURED OR THERE COULD BE A LEAD TO DEVICE INTERFACE ISSUE. THE CONSULTANT RECOMMENDED ADDITIONAL TESTING. THE CALLER WILL LIKELY SCHEDULE THE PATIENT TO COME IN FOR NONINVASIVE PROGRAMMED ELECTRICAL STIMULATION (NIPS) TESTING. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.