System Kit, ALS HDE 20-0045Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00852184003281), received between Dec 1, 2015 and May 3, 2016 — classified as 1 death, 2 injuries.

The most frequently reported specific device problem is “Contamination” (1 report).

1 FDA recall record name this device's identifier.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 31, 2022Class IIITerminated

   Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbol is intended to indicate storage conditions (versus transport conditions or tolerance conditions for the package material).

   Z-1393-2022 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathMay 3, 2016No Pacing; No Pacing

  THE PATIENT WAS IMPLANTED WITH THE SYNAPSE BIOMEDICAL DIAPHRAGM PACING SYSTEM (DPS) DEVICE (B)(6) 2015. THE IMPLANTING SURGEON CONTACTED A SYNAPSE BIOMEDICAL REPRESENTATIVE ON (B)(6) 2016 REPORTING THAT THE PATIENT HAD DIED. HE STATED THAT THE MOTHER OF THE PATIENT HAD LEFT THE PATIENT ALONE WHILE USING THE DPS AND OFF THE MECHANICAL VENTILATOR. WHEN SHE CAME BACK THE PATIENT WAS NOT BREATHING AND THE DPS WAS OFF. ADDITIONAL INFORMATION CAN BE FOUND IN USER FACILITY REPORT NUMBER (B)(4).

  Patient problems: Brain Injury; Death; Hypoxia

  MAUDE report 5628922 ↗
• InjuryDec 1, 2015Contamination

  INFECTION IN ONE OF THE ELECTRODE LEAD TRACKS. THE PATIENT AND SURGEON OPTED TO CUT AFFECTED WIRE AND ADDED A WOUND VAC TO CLEAR UP DRAINAGE.

  Patient problems: Unspecified Infection

  MAUDE report 5266874 ↗
• InjuryDec 1, 2015Material Protrusion/Extrusion

  PATIENT HAD WIRES PROTRUDING FROM THE SKIN. ELECTRODES VISIBLE IN OPEN WOUND NEAR SUB-XYPHOID EXIT/TUNNELING POINT. THE ELECTRODE WAS INITIALLY TUNNELED NEAR THE SKIN SURFACE, EVENTUALLY ERODED THROUGH THE SKIN, EXPOSING ELECTRODE UNDERNEATH. SURGEON RETRACTED THE ELECTRODES FROM LATERAL CHEST AREA TO SUB XIPHOID REGION WHERE THEY WERE TRIMMED AND REBLOCKED. PATIENT CONTINUES TO USE DPS SYSTEM.

  Patient problems: Erosion

  MAUDE report 5266871 ↗