PATCH
Received Apr 9, 2013 · Event occurred Jan 18, 2013
Report 2124215-2013-03416 · MDR key 3044140
Device
Product problems
- High impedance
- Defibrillation/Stimulation Problem
Patient
50 YR
- No Consequences Or Impact To Patient
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 DURING AN ELECTIVE CHANGE OUT PROCEDURE, THIS LEAD EXHIBITED HIGH OUT OF RANGE SHOCKING IMPEDANCE MEASUREMENTS WHEN ATTACHED TO THE COMPETITIVE DEVICE. SINCE THE LEAD'S SHOCK IMPEDANCE MEASUREMENTS WITH THE PREVIOUS BOSTON SCIENTIFIC DEVICE HAD BEEN WITHIN NORMAL RANGE, THE PHYSICIAN PERFORMED DEFIBRILLATION THRESHOLD (DFT) TESTING. USING THE BUST METHOD THE PATIENT WAS INDUCED INTO FIBRILLATION, BUT WAS UNABLE TO BE CONVERTED AND THE SHOCK IMPEDANCE STILL MEASURED GREATER THAN 200 OHMS. SUBSEQUENTLY THE RIGHT VENTRICULAR (RV) PATCH WAS REPLACED WITH A LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.