N/A 27302Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00763000343194), received between Oct 1, 2020 and Feb 7, 2023 — classified as 5 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2023Break; Fracture; Insufficient Device Problem Information; Break; Fracture; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED. THE CATHETER TIP SHEARED OFF THE TOUCHY NEEDLE, WHEN ATTEMPTING TO REPOSITION. IT OCCURRED, WHEN INSERTING A LUMBO-PERITONEAL DRAIN. THE CATHETER WAS INSPECTED BY THE FACILITY, BUT NOT RETURNED TO MEDTRONIC. THERE WAS NO IMPACT TO THE PATIENT. SHE WAS SEEN IN FOLLOW UP. AND NOTIFIED OF ISSUE. THERE WAS DELAY IN PROCEDURE, BECAUSE RADIOLOGICAL EVALUATION OF FLUOROSCOPIC IMAGES WAS FORMALLY REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16311217 ↗
• InjuryOct 13, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL LUMBAR DRAIN SYSTEM. IT WAS REPORTED THE PATIENT UNDERWENT LUMBAR CISTERNA PUNCTURE EXTERNAL DRAINAGE SURGERY AT 11:30 ON (B)(6) 2022, AND LUMBAR EXTERNAL DRAINAGE AND MONITORING SYSTEM WAS PLACED. DURING THE PLACEMENT PROCESS, THE PATIENT'S COOPERATION WAS POOR. THE DRAINAGE TUBE WAS SUCCESSFULLY PLACED. WHEN FIXING THE DRAINAGE TUBE, THE PATIENT MOVED STRONGLY AND CHANGED THE BODY POSITION CAUSING THE DRAINAGE TUBE TO BREAK AT THE SKIN EDGE, AND THE BROKEN END WAS LOCATED INSIDE THE BODY. AN EMERGENCY CT OF THE LUMBAR SPINE WAS PERFORMED TO ASSESS THE LOCATION OF THE BROKEN END, AND THE PROXIMAL OF THE BROKEN END WAS SEEN TO BE LOCATED APPROXIMATELY 1 CM SUBCUTANEOUSLY. AFTER COMMUNICATING WITH THE PATIENT, A SPINAL CANAL FOREIGN BODY REMOVAL SURGERY WAS PERFORMED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15594810 ↗
• MalfunctionSep 13, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A AN EXTERNAL LUMBAR DRAINAGE DEVICE. IT WAS REPORTED THE FLUID COLLECTION CHAMBER WAS FOUND TO BE LEAKING LIQUID ABOVE THE DRAINAGE BAG. THE SITE REPLACED IT WITH A NEW DEVICE AND THE ISSUE WAS RESOLVED. THERE WAS NO REPORTED INJURY AND NO REPORTED DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15411855 ↗
• MalfunctionJun 13, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM (EDMS). IT WAS REPORTED THAT AFTER PLACING A LUMBAR CISTERN EXTERNAL DRAINAGE TUBE, THE TUBE LEAKED LIQUID. THE DOCTOR ASKED THE PATIENT TO CHANGE THE TUBE, "HEREBY EXPLAINED THE SITUATION." THE PRODUCT WAS REPLACED WITH A NEW TUBE. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE CAUSE OF THE ISSUE WAS SUSPECTED TO BE THE LIQUID LEAKAGE PROBLEM. AS THERE WAS A HIGH RISK OF INFECTION IF THE TUBE LEAKED THE LIQUID, IT WAS NOT CHANGED. THIS CONTRADICTS WHAT WAS PREVIOUSLY REPORTED. THE PROCEDURE WAS AN EXTERNAL DRAINAGE OF LUMBAR GREAT POOL SURGERY. IT WAS NOT CLEAR IF THE MALFUNCTION OCCURRED ABOVE OR BELOW THE DRAINAGE BAG. THE PRODUCT WAS NOTED TO BE BLOODSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14680639 ↗
• MalfunctionJan 18, 2022Fracture; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A DRAINAGE PART. DURING THE EXTERNAL DRAINAGE OF THE LUMBAR CISTERN, A PIECE OF THE LUMBAR SPINE CATHETER BROKE OFF IN THE PATIENTS' SPINAL CANAL. THE SITE LEFT APPROXIMATELY 6-7CM IN THE SPINAL CANAL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO SIDE AFFECTS/ADVERSE REACTIONS TO THE CATHETER BREAKING OFF IN THE SPINAL CANAL OF THE PATIENT AS WELL AS NO ADVERSE EVENT OCCURRED WITH THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13286295 ↗
• MalfunctionJan 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A DRAIN BEING USED IN A PROCEDURE. IT WAS REPORTED THAT THE PATIENT UNDERWENT CONTINUOUS DRAINAGE OF LUMBAR CISTERN DUE TO AN INTRACRANIAL INFECTION AFTER A BRAIN TUMOR. MEDTRONIC LUMBAR CISTERN WAS USED. DURING THE SURGERY, DRAINAGE WAS FOUND TO LEAK, AND THEN A NEW DRAIN WAS USED AS A REPLACEMENT. THE SURGERY WAS SUCCESSFULLY COMPLETED. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13170403 ↗
• InjuryNov 22, 2021Fracture; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A DRAINAGE TUBE. ON (B)(6) 2021 THE PATIENT UNDERWENT BRAINSTEM TUMOR RESECTION DUE TO A BRAINSTEM TUMOR. ON (B)(6) 2021 THE DRAINAGE TUBE WAS REMOVED, AND IT WAS DECIDED TO PERFORM LUMBAR CISTERN DRAINAGE TUBE IMPLANTATION. FIRST THE SITE USED IT BETWEEN L3 AND 4, AND USED THE NO. 9 LUMBAR PUNCTURE PACKAGE TO SUCCESSFULLY PUNCTURE, AND RECORDED THE DEPTH OF THE PUNCTURE NEEDLE. THEN, THEY FOLLOWED THE INSTRUCTIONS OF MEDTRONIC LUMBAR DRAINAGE KIT, AND USED THE PUNCTURE NEEDLE (THICKER, ABOUT 1MM IN DIAMETER) IN THE KIT TO PUNCTURE INTO THE SUBARACHNOID SPACE. ON THE OPPOSITE SIDE OF THE NEEDLE PORT, THEY INSERTED THE GUIDE WIRE INTO THE DRAINAGE TUBE OF THE LUMBAR CISTERN. THEN INSERTED THE DRAINAGE TUBE WITH THE GUIDE WIRE THROUGH THE PUNCTURE NEEDLE INTO THE SUBARACHNOID SPACE ABOUT 8CM. THEY REMOVED THE GUIDE WIRE AND IT WAS NOT SMOOTH, AND THE DRAINAGE OF THE CEREBROSPINAL FLUID WAS NOT SMOOTH AFTER REMOVAL. IT WAS PLANNED TO PUNCTURE THE CATHETER AGAIN, AND AFTER REMOVING THE CATHETER, IT WAS FOUND THAT THERE WAS A FRACTURE. AN EMERGENCY CT SCAN REVEALED THAT SOME OF THE CATHETER'S BROKEN ENDS REMAINED IN THE SPINAL CANAL, ENTWINING TH

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12852311 ↗
• MalfunctionNov 15, 2021Break; Fracture; Break; Fracture

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE REPORTED EVENT WAS A DOCTOR'S OPERATION PROBLEM THAT CAUSED THE TUBE TO BREAK. THE TUBE WAS BRAND NEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12816082 ↗
• MalfunctionNov 2, 2021Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12738775 ↗
• InjurySep 20, 2021Complete Blockage; Complete Blockage

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT SUFFERED FROM INTRACRANIAL HEMORRHAGE WHICH CAUSED BLOOD CLOTS IN THE CEREBROSPINAL FLUID OF THE SUBARACHNOID SPACE WHICH LED TO THE UNSMOOTH DRAINAGE OF THE LUMBAR CISTERN. AFTER THE INTRACRANIAL HEMORRHAGE WAS TREATED, THE PROBLEM WAS SOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12498829 ↗
• MalfunctionSep 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT IN THE PROCESS OF DRAINAGE, IT WAS FOUND THAT THE BOTTOM OF THE EFFUSION CHAMBER WAS LEAKING. THE DEVICE WAS REPLACE WITH ANOTHER ONE OF THE SAME MODEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12441380 ↗
• MalfunctionSep 8, 2021Break; Fracture; Break; Fracture

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ISSUE WAS RESOLVED BY CHANGING TO GENERAL ANESTHESIA, INCISED THE LAMINA LIGAMENT, FOUND THE BROKEN END, AND PULLED IT OUT. THE PATIENT RETURNED TO NORMAL AFTER THE LUMBAR CISTERN PROCEDURE. THIS RESULTED IN A PROCEDURE DELAY OF 60 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12439780 ↗
• MalfunctionAug 9, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE LEAKED IN THE MIDDLE POSITION OF THE DRAINAGE TUBE. THERE WERE NO ENVIRONME NTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12297857 ↗
• MalfunctionJul 30, 2021Complete Blockage; Complete Blockage

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CUSTOMER STATED THAT THE SYSTEM WAS NOT CIRCULATING SMOOTHLY, AND IT WAS SUSPECTED THAT THE TUBE WAS BLOCKED AT THE ANTI-REFLUX POSITION OF THE SYSTEM. THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12254196 ↗
• MalfunctionJul 2, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE CEREBROSPINAL FLUID WOULD NOT DRAIN OUT WHEN USING THE EXTERNAL DRAINAGE FOR SURGERY. AS A RESULT, IT WAS REPLACED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12110338 ↗
• MalfunctionMay 18, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE DEVICE LEAKED ABOUT 15CM FROM THE TIP. THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11843868 ↗
• MalfunctionApr 28, 2021Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11739033 ↗
• InjuryApr 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED, REPORTED THAT THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS, THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: Unspecified Infection

  MAUDE report 11634515 ↗
• InjuryJan 8, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT EXTERNAL DRAINAGE OF CEREBROSPINAL FLUID AFTER RESECTION OF A GLIOMA RECURRENCE. THE DOCTOR PLACED A DRAINAGE TUBE IN THE LUMBAR CISTERN OF THE PATIENT ON (B)(6) 2020, AND ON (B)(6) 2020, THE NURSE CHECKED THAT THE TUBE WAS PROPERLY FIXED, AND THE DRAINAGE FLOW WAS SMOOTH. HOWEVER, LATER THAT NIGHT, THE NURSE FOUND THAT THE PATIENT'S BED SHEETS WERE WET, AND THE DRAINAGE TUBE WAS FOUND TO BE BROKEN AFTER FURTHER EXAMINATION. THE NURSE IMMEDIATELY TURNED THE STUMP OF THE DRAINAGE TUBE ON THE PATIENT'S SIDE WHEN THE BROKEN TUBE WAS FOUND AND REPORTED TO THE DOCTOR ON DUTY. THE DOCTOR PULLED OUT THE DRAINAGE TUBE AT THE BEDSIDE AND ASKED TO PAY CLOSE ATTENTION TO CHANGES IN THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11140746 ↗
• MalfunctionDec 22, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CONTINUOUS LUMBAR CISTERN DRAINAGE DUE TO SUBARACHNOID HEMORRHAGE. DURING THE SURGERY, THE DOCTOR SUCCESSFULLY PLACED THE LUMBAR SPINAL CANAL INTO THE SPINAL CANAL; HOWEVER, THEY FOUND THAT THERE WAS CEREBROSPINAL FLUID LEAKING FROM THE WALL OF THE DRAINAGE TUBE ABOUT 18CM AWAY FROM THE END OF THE DRAINAGE TUBE. THE DEVICE WAS REPLACED WITH A NEW ONE, AND THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11055598 ↗
• MalfunctionOct 1, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE DOCTOR OPENED THE DEVICE, AND THE TIP WAS BROKEN ON THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10615354 ↗