ISOLINE

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY TO THE CLINIC VIA DATA TRANSMISSION FORM THEIR ICD DEVICE. UPON EXAMINATION, MULTIPLE EPISODES OF OVERSENSING WITH VERY LOW R-WAVES (2 MV) WERE OBSERVED. THE PHYSICIAN SUSPECTED THAT THE OVERSENSING MAY BE DUE TO MYOPOTENTIAL OVERSENSING. THE PHYSICIAN ALSO REPORTED EPISODES OF POST-PACED T-WAVE OVERSENSING BECAUSE OF THE SMALL R-WAVES AND SOME EPISODES OF UNDERSENSING RESULTING FROM PROGRAMMING CHANGES TO AVOID THE T-WAVE OVERSENSING. DUE TO THE SMALL R-WAVE, THE RIGHT VENTRICULAR (RV) LEAD WAS EITHER OVERSENSING OR UNDERSENSING. THE PATIENT DID NOT RECEIVE ANY INAPPROPRIATE THERAPY FROM THE RV LEAD OVERSENSING OR UNDERSENSING AND THE PATIENT IS NOT PULSE-GENERATOR DEPENDENT. IT WAS RECOMMENDED THAT THE PATIENT BE BROUGHT IN TO PERFORM ISOMETRIC TESTING TO DETERMINE IF A NEW RV LEAD IS REQUIRED. THERE WAS NO ADVERSE CONSEQUENCE REPORTED FOR THE PATIENT. NO MORE INFORMATION AVAILABLE.

Additional Manufacturer Narrative

AS NO INFORMATION WAS PROVIDED AND AS THE SERIAL NUMBER OF THE LEAD IS UNKNOWN AND THE LEAD IS NOT RETURNED TO BE ANALYSIS, NO CONCLUSION COULD BE ESTABLISHED. THE EVENT IS RECOVERED IN OUR DATABASE FOR TRENDS PURPOSES. THE IMPLANTATION DATE IS ALSO UNKNOWN.