UNKNOWN
Received Jul 6, 2012 · Event occurred Apr 10, 2012
Report 2124215-2012-07335 · MDR key 2642457
Device
Product problems
- Pacing Problem
- Appropriate Device Problem Term/Code Not Available
Patient
61 YR
- Unspecified Infection
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 PRODUCT IS SCHEDULED FOR A SYSTEM REVISION IN THE FUTURE DUE TO INFECTION. THE DEVICE WILL BE EXPLANTED AND A NEW DEVICE INSERTED DEEPER INTO THE POCKET. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS RECEIVED THAT DURING A DEVICE REPLACEMENT PROCEDURE, THE IMPLANTED SYSTEM WAS REMOVED AND REPLACED WITH LASER EXTRACTION AND IMPLANTED THROUGH THE RIGHT SUBCLAVIAN VEIN. ALL LEADS AND THE DEVICE WERE REMOVED EXCEPT THE DISTAL PART OF THE 4471 RV-P/S LEAD WAS NOTED TO BE RIPPED IN TWO PIECES DURING THE EXTRACTION. THE SYSTEM WAS SUCCESSFULLY TESTED WITH AND INDUCED T-WAVE SHOCK (1,1J) DURING THE IMPLANT PROCEDURE AND CAUSED VENTRICULAR FIBRILATION WHICH WAS TERMINATED BY THE FIRST SHOCK WITH 31J. NO ADVERSE PATIENT EFFECTS WERE REPORTED.