Items tagged #adverse-event
Reported to the FDA Sep 7, 2026 (event Mar 24, 2026). The FDA publishes these reports weeks after receipt. Philips reviewed the reported complaint requesting ISCV design such that there is no direct connection required to database from thick client.Based on the results of the investigat
Reported to the FDA Sep 8, 2026 (event Apr 7, 2026). The FDA publishes these reports weeks after receipt. A user alleged hacking; the report contains no confirmed cybersecurity finding.
Reported to the FDA Sep 29, 2026 (event Sep 2, 2026). The FDA publishes these reports weeks after receipt. D.4 & H.4: Serial Number, Unique Device Identifier, and Manufacturer Date not available.Upon investigation of the actual device used in this incident, it was determined that the fa
Reported to the FDA Sep 25, 2026 (event Jan 20, 2025). The FDA publishes these reports weeks after receipt. A user alleged hacking; the report contains no confirmed cybersecurity finding.
Reported to the FDA Sep 22, 2026 (event Dec 6, 2024). The FDA publishes these reports weeks after receipt. The customer reported receiving unexpectedly high Access hsTnI (Part Number B52699) patient results on an Access 2 Analyzer (serial number (b)(6)). No adverse patient impact, injur
Reported to the FDA Sep 8, 2026 (event Aug 26, 2026). The FDA publishes these reports weeks after receipt. A user alleged hacking; the report contains no confirmed cybersecurity finding.
Analysis synthesis:Review of the software analysis confirmed the reported behavior during the LBBOT procedure, with spontaneous QRS complexes incorrectly detected as pacing spikes, leading to inappropriate measurements.The investigation showed that a specific QRS morphology on le
Reported to the FDA Aug 19, 2026. The FDA publishes these reports weeks after receipt. A user alleged hacking; the report contains no confirmed cybersecurity finding.
Information was received from a patient who was implanted with an implantable neurostimulator (INS) for urinary/bowel dysfunction. It was reported that since they started having bronchitis in (b)(6) of this year, their therapy wouldn't let them go past 1.3 mA. The patient attempt
NA. ARC-One Solutions received information regarding Regulated Software Application (RSA), Version 2.0 (BK200512). Specifically, an issue related to importing blood products into RSA 2.0 from a blood center's own facility, and the ability to ship these products to customers for
It was reported by the patient that they received a letter from Medtronic indicating that there was a personal data breach. The Impl antable Pulse Generator (IPG) remains in use. No patient complications have been reported as a result of this event. Correction: B5 Medtronic subm
Reported to the FDA Aug 24, 2026. The FDA publishes these reports weeks after receipt. A user alleged hacking; the report contains no confirmed cybersecurity finding.
