PATCH
Received Jan 7, 2011 · Event occurred Dec 7, 2010
Report 2124215-2010-23681 · MDR key 1952756
Device
Product problems
- High impedance
Patient
Not reported
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Additional Manufacturer Narrative
THE LEADS REMAIN IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED AND AN AMENDED REPORT SUBMITTED.
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THREE MONTHS AGO, THE SHOCK IMPEDANCE VALUES WERE HIGHER THAN 125 OHMS. ON (B)(6) 2010 THE VALUES WERE BETWEEN 60 TO 70 OHMS. THE PATIENT HAS TWO EPICARDIAL DEFIBRILLATION LEADS IMPLANTED (MODELS 0067 AND 0068, SERIAL NUMBERS UNKNOWN) AND A COMPETITOR PACE/SENSE LEAD. A SHOCK TEST WAS NOT PERFORMED DUE TO THE PATIENTS POOR CONDITION. THE LEADS WILL REMAIN IMPLANTED AND MONITORED CLOSELY EVERY THREE MONTHS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.