Description of Event or Problem · 0
MEDICAL DEVICE ZIO-AT PATCH MANUFACTURED BY IRHYTHM TECHNOLOGIES; INC. HAS ALREADY BEEN THE SUBJECT OF AN FDA WARNING LETTER. (B)(4). ON (B)(6) 2025, I UNDERWENT A TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE. I WAS FITTED WITH A ZIO-AT CARDIO MONITORING PATCH AT THE TIME OF HOSPITAL DISCHARGE ON (B)(6) 2025. THE DEVICE WAS SUPPOSED TO BE WORN FOR 14 DAYS. ON (B)(6) 2025, I RECEIVED A TELEPHONE CALL FROM AN IRHYTHM REPRESENTATIVE WHO SAID THERE WAS SOME ANOMALY WITH THE PATCH AND DIRECTED ME TO REMOVE AND RETURN IT TO IRHYTHM VIA PREPAID USPS SHIPPING. THIS WAS ACCOMPLISHED ON (B)(6) 2025 WHEN THE REPLACEMENT PATCH ARRIVED AT MY HOME. USPS DELIVERED THE DEFECTIVE PATCH TO IRHYTHM ON (B)(6) 2025. I WORE THE SECOND ZIO-AT PATCH AS DIRECTED UNTIL (B)(6) 2025, THEN ALSO REMOVING, AND RETURNING THAT UNIT TO IRHYTHM AS WELL. USPS DELIVERED THE SECOND PATCH TO IRHYTHM ON (B)(6) 2025. IN THE MEANTIME, ON (B)(6) 2025, CARDIOLOGIST DR. (B)(6) TELEPHONED ME AT HOME TO ADVISE THAT IT WAS URGENT THAT I REPORT TO THE ER AT (B)(6) WITHOUT DELAY FOR PROBABLE PACEMAKER IMPLANTATION SURGERY, WHICH DID IN FACT OCCUR ON THE FOLLOWING DAY. (B)(6) SUBSEQUENTLY EXPLAINED THAT ON (B)(6) 2025, IRHYTHM INFORMED HIM THAT ON (B)(6) 2025, I EXPERIENCED A SERIES OF "HIGH GRADE AV BLOCKS" AS DETECTED BY THEIR ZIO-AT PATCH. TO DATE THERE REMAINS UNRESOLVED CONTROVERSY AS TO WHY IT TOOK IRHYTHM TECHNOLOGIES 16 DAYS TO ALERT DR. (B)(6) RE: THE HIGH-GRADE AV BLOCKS. ON (B)(6) 2025, I SPOKE BY TELEPHONE WITH "(B)(6) OF THE CLINICAL TEAM" AT IRHYTHM. HE TOLD ME THAT THE (B)(6) HIGH GRADE AV BLOCKS WERE NOT PICKED UP/NOTICED DURING THE TIME I WAS WEARING THE PATCH, AND ONLY CAME TO LIGHT AFTER THAT DEVICE WAS RETURNED TO IRHYTHM AND ANALYZED. ON (B)(6) 2025, I COMPLETED AN ONLINE REQUEST FOR MY RECORDS AT (B)(4). ON (B)(6) 2025, I SENT A CERTIFIED LETTER TO IRHYTHM REQUESTING COPIES OF MY MEDICAL RECORDS. TO DATE IRHYTHM HAS NOT RESPONDED TO MY REQUESTS. ON (B)(6)2025, I FILED A HIPAA PRIVACY COMPLAINT WITH THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, OFFICE FOR CIVIL RIGHTS, OCR TRANSACTION NUMBER (B)(4).