NA 44111Recalls & reported problems
Medtronic Ps Medical, Inc. · RESERVOIR 44111 VENT. BURR HOLE · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169466746), received between Dec 28, 2018 and Sep 6, 2023 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Break1
- Fracture1
Patient problems
- Erosion1
- Fatigue1
- Fever1
- Meningitis1
- Muscular Rigidity1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
- Swelling1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 6, 2023Break; Fracture; Break; Fracture
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE STYLET WAS BENT UPON REMOVAL FROM THE BOX, AND IT WAS STILL IN ITS STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17692887 ↗InjuryMay 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT PRESENTED TO THE EMERGENCY AFTER A SCAB OVER THE DEVICE FELL OFF EXPOSING THE DEVICE. IT WAS NOTED THE PATIENT HAD INTERMITTENT TRAUMA TO THE SITE OVER THE PREVIOUS WEEKS. THE PATIENT WAS ADMITTED TO THE HOSPITAL, AND THE DEVICE WAS REMOVED DUE TO INFECTION RISK. THE PATIENT UNDERWENT ANTIBIOTIC TREATMENT AND WAS RELEASED FROM THE HOSPITAL WITH NO SEQUELA. IT WAS INDICATED THAT THE PATIENT WAS IMPLANTED FOR ACCESS OF CEREBROSPINAL FLUID FOR PK ANALYSIS.
Patient problems: Erosion
MAUDE report 8653825 ↗InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED REPORTED THE OUTCOME OF THE EVENT WAS UPDATED TO RECOVERED/RESOLVED ON (B)(6) 2018.
Patient problems: Fatigue; Fever; Meningitis; Muscular Rigidity; Pain; Swelling; Vomiting
MAUDE report 8203277 ↗
Other Shunt, central nervous system and components devices
- NATUS EDS3 DRAINAGE SYSTEM NT821731CNatus Medical Incorporated · Shunt, Central Nervous System And Components1 recall208 reports
- Exacta™ 46700Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall2 deaths163 reports
- Strata® 42866Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 death160 reports
- proGAV 2.0® FX410TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components119 reports
- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.