EDM 27637 (UDI 00763000030261)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000030261), received between May 11, 2023 and Apr 2, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM CATHETER. IT WAS REPORTED THAT DURING THE SURGERY OF VENTRICULOCENTESIS, WHEN USING NORMAL SALINE TO CHECK THE AIR TIGHTNESS, IT WAS FOUND THAT THE CATHETER LEAKED. THE CATHETER WAS REPLACED WITH A NEW ONE. THE PATIENT'S MEDICAL HISTORY WAS COMMUNICATING HYDROCEPHALUS CAUSED BY A CAR ACCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19018553 ↗
• InjuryMay 11, 2023Loose or Intermittent Connection; Device Dislodged or Dislocated; Loose or Intermittent Connection; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. IT WAS REPORTED THAT THE INTERFACE BETWEEN THE VENTRICULAR DRAINAGE TUBE AND THE DRAINAGE BAG WAS LOOSE. UNDER GENERAL ANESTHESIA, THE PATIENT UNDERWENT 1. INTRACEREBRAL HEMATOMA EVACUATION, 2. SKULL DRILLING AND DRAINAGE, 3. SUBTEMPORAL DECOMPRESSION, 4. VENTRICULAR SHUNT, WITH INDWELLING VENTRICULAR DRAINAGE TUBE. ON 04-03, A CT EXAMINATION WAS PERFORMED AROUND 10:00. DURING THE EXAMINATION IN THE CT ROOM,THE VENTRICULAR DRAINAGE TUBE AND DRAINAGE DEVICE FELL OFF. THE CAUSE OF THE EVENT WAS REPORTED THE DRAINAGE TUBE CONNECTOR WAS NOT SECURE. THE PATIENT WAS RETURNED TO THE INTENSIVE CARE UNIT IMMEDIATELY, AND THE VENTRICULAR DRAINAGE TUBE WAS CLAMPED WITH HEMOSTATIC FORCEPS. THE PATIENT'S VITAL SIGNS, CONSCIOUSNESS, AND PUPILS WERE OBSERVED. AFTER INFORMING THE DOCTOR, THE VENTRICULAR DRAINAGE TUBE WAS REMOVED, AND THEN THE LUMBAR DRAINAGE TUBE WAS INDWELLED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16910592 ↗