PATCH

Description of Event or Problem

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATCH LEAD DISPLAYED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. A CHEST X-RAY WILL BE PERFORMED IN THE NEAR FUTURE TO SEE IF THERE IS A VISIBLE LEAD OR SETSCREW ISSUE. THE PATIENT IS CURRENTLY PROGRAMMED TO MONITOR ONLY (MO), AND WILL REMAIN IN THE HOSPITAL UNTIL THIS ISSUE IS RESOLVED. A SAVE TO DISK WAS REVIEWED BY TECHNICAL SERVICES (TS). TS CONFIRMED THERE WERE HIGH OOR SHOCK IMPEDANCE MEASUREMENTS. THERE WAS NO NOISE OBSERVED ON THE ELECTROGRAM, AND THE RV PACING IMPEDANCE WAS STABLE AND WITHIN RANGE. TS PROVIDED TROUBLESHOOTING METHODS TO HELP FIND THE CAUSE FOR OOR SHOCK IMPEDANCE MEASUREMENTS. TROUBLESHOOTING METHODS WERE ATTEMPTED. NOISE WAS NOT OBSERVED WHEN THE POCKET WAS MANIPULATED. SEVERAL SHOCK IMPEDANCE TESTS WERE PERFORMED, INCLUDING 1:1 JOULE COMMANDED SHOCKS, WHICH AGAIN REVEALED OOR SHOCK IMPEDANCE MEASUREMENTS. A CHEST X-RAY WAS PERFORMED, BUT NO ANOMALIES NOTED. TS DISCUSSED THAT THE BEST EXPLANATION FOR THE OOR MEASUREMENTS IS A CONDUCTOR OR MESH FRACTURE, OR LOOSE SET SCREW SOMEWHERE ON THE PATCH ELECTRODE CONNECTED TO THE DISTAL COIL PORT OF THE PG. TS SUGGESTED A HIGH RESOLUTION X-RAY BE PERFORMED, AND TO CHECK THAT THE RV AND LEFT VENTRICULAR (LV) PATCHES ARE CONNECTED PROPERLY. THE PHYSICIAN STATED THAT THIS PATIENT WILL BE FOLLOWED-UP IN THE NEAR FUTURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. SUBSEQUENTLY, A FOLLOW-UP PROCEDURE WAS PERFORMED. AN OPEN MEASUREMENT ON THE SYSTEM WAS PERFORMED, AND IT WAS OBSERVED THERE WAS AN ISSUE WITH THIS 0068 DISTAL PATCH LEAD. THE DECISION WAS MADE TO IMPLANT A COMPETITOR SQ LEAD. ONCE CONNECTED TO THE ASSOCIATED 0067 PATCH LEAD AND ICD, ALL MEASUREMENTS WERE NORMAL AND WITHIN RANGE.

Additional Manufacturer Narrative

THIS PATCH LEAD WAS SURGICALLY ABANDONED. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.