N/A 44111Recalls & reported problems
Medtronic Ps Medical, Inc. · RESERVOIR 44111 VENT. BURR HOLE · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000028220), received between Apr 20, 2022 and Feb 21, 2023 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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.
Most reported problems
Device problems
- Break2
- Fracture2
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Tissue Injury1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 21, 2023Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING A RESERVOIR. IT WAS REPORTED THAT AFTER IMPLANTING, THE SITE TESTED THE RESERVOIR AND REALIZED THAT THE IMPLANT WAS FAULTY AS SHE NOTICED BACKFLOW AND LEAKING FROM THE RESERVOIR. THEY IMMEDIATELY REMOVE AND REPLACE WITH ANOTHER. THE OPERATION WAS SUCCESSFUL AFTER THE REPLACEMENT WAS DONE. PATIENT IS SAFE AND RECOVERING. THE ITEM WAS INITIALLY IMPLANTED BEFORE SWITCHING UP, THE HEALTH CARE PROFESSIONAL TRIED TO CHECK THE FLOW AND REALIZED THE BACKFLOW. THE FAULTY RESERVOIR WAS THEN REMOVED AND REPLACED WITH A NEW RESERVOIR WITH THE SAME PART NUMBER. THEREFORE, THE FAULTY RESERVOIR WAS NOT IMPLANTED IN PATIENT.
Patient problems: Unspecified Tissue Injury
MAUDE report 16409243 ↗MalfunctionAug 26, 2022Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING A BURR HOLE USED OUTSIDE OF A PROCEDURE.. IT WAS REPORTED THAT THE TIP WAS SKEWED, AND THE DOCTOR JUDGED THAT IT COULD NOT BE USED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15302913 ↗MalfunctionApr 20, 2022Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING A RESERVOIR BURR HOLE. IT WAS REPORTED THAT DURING EMERGENCY SURGERY, THE DOCTOR FOUND THAT THE FRONT END WAS SKEWED AND UNUSABLE. NO DELAY OR PATIENT IMPACT INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14162025 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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