ATTAIN STARFIX™ 419578Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169590632), received between Sep 4, 2019 and Sep 4, 2019 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A DEVICE CHECK AND DIAPHRAGMATIC STIMULATION WAS OBSERVED. THE PATIENT NOTED THEY HAD EXPERIENCED DIAPHRAGMATIC STIMULATION SINCE IMPLANT OF THE LEFT VENTRICULAR (LV) LEAD TWO YEARS PRIOR, HOWEVER, DID NOT REPORT IT TO THE CLINIC. THE NURSE ATTEMPTED TO REPROGRAM THE LV LEAD TO ALLEVIATE THE STIMULATION TO NO AVAIL. AFTER REVIEW WITH THE PHYSICIAN, IT WAS DECIDED TO PROGRAM THE LV LEAD OFF. THE LV LEAD REMAINS IN-SITU. THE PATIENT IS A PARTICIPANT IN THE POST APPROVAL CLINICAL SURVEILLANCE PRODUCT SURVEILLANCE REGISTRY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Muscle Stimulation

  MAUDE report 8961905 ↗