N/A 27303 (UDI 00763000395988)Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00763000395988), received between Jun 13, 2022 and Sep 11, 2026 — classified as 10 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Break” (39 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 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Fluid/Blood Leak

  Medtronic received information regarding an external drainage and monitoring system. It was reported that there was leakage from the drainage bag from the connection point. No patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50734999 ↗
• MalfunctionMay 26, 2026Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR TREATMENT AFTER INTRACEREBRAL HEMORRHAGE. LUMBAR PUNCTURE WITH EXTERNAL DRAINAGE OF CEREBROSPINAL FLUID WAS PLANNED. AFTER IMPLANTATION, CEREBROSPINAL FLUID LEAKAGE WAS OBSERVED FROM THE OUTER WALL OF THE LUMBAR CISTERN DRAINAGE CATHETER. THE PRODUCT WAS CONSIDERED DAMAGED AND POSED A SIGNIFICANT RISK OF INFECTION, SO THE IMPLANTATION WAS DISCONTINUED. THE SURGERY WAS COMPLETED SUCCESSFULLY ONLY AFTER A BRAND-NEW BACK UP PRODUCT WAS USED. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-WITH INJURY, HOWEVER, THE INJURY REFERS TO THE CAUSE OF THE PATIENT'S CONDITION AT ADMISSION, MAINLY HYDROCEPHALUSAND NOT RELATED TO THE REPORTED DEVICE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25278136 ↗
• MalfunctionMay 22, 2026Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE PATIENT DEVELOPED INTR ACRANIAL INFECTION AFTER SURGERY FOR A LUMBAR EPIDURAL CYST AND UNDERWENT LUMBAR CISTERN DRAINAGE UNDER LOCAL INFILTRATION ANESTHESIA ON (B)(6) 2026, TO DRAIN INFECTED CEREBROSPINAL FLUID. THE LUMBAR CISTERN DRAINAGE TUBE WAS PROPERLY SECURED AND RELATED PRECAU TIONS WERE EXPLAINED. AS THE PATIENT¿S CONDITION IMPROVED, DURING THE WARD ROUND ON (B)(6) 2026, THE ATTENDING PHYSICIAN INFORMED THE PATIENT AND FAMILY THAT THE LUMBAR CISTERN DRAINAGE TUBE WOULD LIKELY BE REMOVED WITHIN THE NEXT TWO DAYS. ON (B)(6) 2026, WHILE THE PATIENT¿S FAMILY MEMBER WAS REMOVING LOOSE THREADS FROM THE HEM OF THE PATIENT¿S CLOTHING, THEY DID NOT NOTICE THAT THE THREAD WAS ENTANGLED WITH THE LUMBAR CISTERN DRAINAGE TUBE AND ACCIDENTALLY STRANGULATED AND BROKE THE DRAINAGE TUBE APPROXIMATELY 8 CM FROM THE DRAINAGE OUTLET. THE PHYSICIAN WAS IMMEDIATELY NOTIFIED. A STERILE VASCULAR CLAMP WAS USED TO CLAMP THE DRAINAGE TUBE NEAR THE PATIENT END TO PREVENT CEREBROSPINAL FLUID LEAKAGE AND AIR FROM ENTERING THE SPINAL CANAL, THEREBY AVOIDING THE RISK OF INTRACRANIAL INFECTION OR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25254646 ↗
• InjuryMar 19, 2026Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE PATIENT HAD A LEFT CER EBELLAR MENINGIOMA DISCOVERED SIX MONTHS AGO AND UNDERWENT GAMMA KNIFE TREATMENT FOR MORE THAN FIVE MONTHS. SEEKING FURTHER SURGICAL CURE, THE PATIENT VISITED OUR OUTPATIENT CLINIC AND WAS ADMITTED TO THE NEUROSURGERY DEPARTMENT WITH A DIAGNOSIS OF LEFT CEREBELLAR MENINGIOMA. AFTER ADMISSION, ROUTINE BLOOD, URINE, AND STOOL TESTS, LIVER AND KIDNEY FUNCTION TESTS, BLOOD GLUCOSE, COAGULATION FUNCTION, CROSSMATCH, ECG, CHEST AND ABDOMINAL CT, CARDIAC ULTRASOUND, AND ENHANCED CRANIAL MRI WERE PERFORMED TO CLARIFY THE DIAGNOSIS. SURGERY WAS SCHEDULED, AND ON (B)(6) 2026, UNDER GENERAL ANESTHESIA WITH ENDOTRACHEAL INTUBATION, THE PATIENT UNDERWENT LEFT RE TROSIGMOID CRANIOTOMY FOR MICROSURGICAL REMOVAL OF THE LEFT CEREBELLAR HEMISPHERE MENINGIOMA, CEREBROSPINAL FLUID LEAK REPAIR, DECOMPRESSIVE CRANIECTOMY, EPIDURAL DRAINAGE, AND LUMBAR POND DRAINAGE. ON (B)(6) 2026, A LUMBAR POND DRAINAGE DEVICE WAS USED TO PLACE A LUMBAR POND CATHETER FOR CEREBROSPINAL FLUID DRAINAGE. DURING PLACEMENT, THE DOCTOR FOUND THAT THE BUILT-IN THREE-WAY VALVE OF THE DRAINAGE DEVI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638206 ↗
• MalfunctionMar 9, 2026Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE OPERATOR DISCOVERED THAT THE COMPONENT WAS DAMAGED WHEN USE WAS REQUIRED, SO IT WAS REPLACED WITH A NEW ONE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544080 ↗
• InjuryFeb 2, 2026Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE PATIENT REQUIRED DRAINAGE OF BLOODY CEREBROSPINAL FLUID. ON (B)(6) 2026, THE DOCTOR PERFORMED A LUMBAR POND DRAINAGE PROCEDURE FOR THE PATIENT. THE PROCEDURE WENT SMOOTHLY, AND THE PATIENT EXPERIENCED NO DISCOMFORT DURING OR AFTER THE SURGERY. ON THE EVENING OF (B)(6) 2026, THE NURSE DISCOVERED THAT THE LUMBAR POND DRAINAGE TUBE HAD FRACTURED DURING ROUNDS AND IMMEDIATELY INFORMED THE ON-DUTY DOCTOR. THE ON-DUTY DOCTOR PROMPTLY REMOVED THE LUMBAR POND DRAINAGE TUBE AND PERFORMED WOUND CARE, MONITORED THE PATIENT'S VITAL SIGNS, LEVEL OF CONSCIOUSNESS, AND PUPIL CHANGES, AND CHECKED FOR SIGNS OF BRAIN INJURY. SUBSEQUENT TREATMENT INCLUDED LUMBAR PUNCTURE TO DRAIN BLOODY CEREBROSPINAL FLUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234870 ↗
• MalfunctionJan 29, 2026Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2026, WHEN THE HOSPITAL USED THE REPORTED DEVICE, THE PUNCTURE NEEDLE WAS FOUND TO BE DEFORMED AND BENT, AFFECTING NORMAL USE. THE DEVICE WAS REPLACED IMMEDIATELY. NO IMPACT WAS CAUSED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209648 ↗
• MalfunctionJan 9, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT AFTER TUBE PLACEMENT, LEAKAGE WAS FOUND. THE DOCTOR IMMEDIATELY REPLACED IT WITH A NEW TUBE, AND THE TUBE WAS REINSERTED TO COMPLETE THE SURGERY. THERE WAS A PROCEDURE DELAY OF 10 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019102 ↗
• InjuryJan 5, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THAT DURING THE TUBE PLACEMENT PROCEDURE, THE DOCTOR FOUND THAT LUMBAR DRAINAGE FLUID WAS LEAKING FROM THE MIDDLE OF THE TUBE, WHICH LED TO CEREBROSPINAL FLUID LOSS. A NEW SET OF TUBE WAS IMMEDIATELY USED INSTEAD.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23961096 ↗
• MalfunctionDec 29, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT LUMBAR CISTERN DRAINAGE, AND THE DEVICE WAS PROPERLY SECURED. ON (B)(6) 2025, DURING PATIENT INSPECTION, THE DRAINAGE TUBE WAS FOUND TO BE BROKEN. A NEW TUBE WAS IMMEDIATELY REPLACED AND FIXED, AND NO SIGNIFICANT HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905243 ↗
• MalfunctionDec 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DURING THE LUMBAR CISTERN DRAINAGE CATHETER PLACEMENT PROCEDURE, A LEAK WAS DISCOVERED IN THE CATHETER LUMEN. THE CATHETER WAS THEN REMOVED, AND REPLACED WITH A NEW CATHETER TO COMPLETE THE SURGERY. THERE WAS A PROCEDURE DELAY OF 40 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905205 ↗
• MalfunctionDec 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THERE WAS LEAKAGE DURING THE PRE-FILLING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23766883 ↗
• MalfunctionDec 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT IN THE SECOND NEUROSURGERY WARD OF THE HOSPITAL, FLUID LEAKAGE OCCURRED WHILE USING THE LUMBAR CISTERNAL DRAINAGE DEVICE, MAKING IT UNUSABLE AND AFFECTING THE PATIENT'S CONDITION. THE DEVICE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692023 ↗
• MalfunctionDec 2, 2025Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT WAS TRANSFERRED BY WHEELCHAIR FROM THE REHABILITATION DEPARTMENT WITH A DIAGNOSIS OF "RECOVERY STAGE OF CRANIOCEREBRAL TRAUMA AND HYDROCEPHALUS," AND HAD A GCS SCORE OF E4+V2+M5=11. ON (B)(6) 2025, UNDER STERILE CONDITIONS, THE PHYSICIAN PERFORMED "LUMBAR PUNCTURE AND PLACEMENT OF EXTERNAL LUMBAR CISTERNAL DRAINAGE." THE DRAINAGE WAS UNOBSTRUCTED, THE FLUID WAS CLEAR AND TRANSPARENT, AND THE DEVICE WAS PROPERLY SECURED. THE WHITE TUBE OF THE LUMBAR CISTERNAL DRAINAGE DEVICE, AT THE JUNCTION WITH THE HARD TUBE, WAS WRAPPED WITH GAUZE AND FIXED TO THE PATIENT¿S RIGHT ABDOMEN. ON (B)(6) 2025, THE PATIENT'S FAMILY DISCOVERED THAT THE WHITE TUBE OF THE LUMBAR CISTERNAL DRAINAGE DEVICE HAD BROKEN AND WAS LEAKING FLUID, AND IMMEDIATELY REPORTED IT TO THE DOCTOR. THE PHYSICIAN REMOVED THE LUMBAR CISTERNAL DRAINAGE TUBE AT THE BEDSIDE. THE WHITE TUBE (NON-CONNECTOR PART) OF THE LUMBAR CISTERNAL DRAINAGE DEVICE FRACTURED. THE WHITE CATHETER SHOWED CHAPPING AND THE BREAK WAS IRREGULAR, NOT CAUSED BY SHARP INSTRUMENT INJURY OR VIOLENT MANUAL TEARING. THE TUBE CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23691936 ↗
• MalfunctionNov 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DURING THE SURGERY, IT WAS DISCOVERED THAT THE TUBE HAD A LIQUID LEAK. THE TUBE WAS REPLACED TO ENSURE THE SURGERY COULD PROCEED SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23655621 ↗
• MalfunctionNov 24, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2025, IN THE OPERATING ROOM, THE DOCTOR ENCOUNTERED A BENT PUNCTURE NEEDLE TIP DURING A LUMBAR EXTERNAL DRAINAGE PROCEDURE, RESULTING IN PUNCTURE FAILURE. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT TWICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631516 ↗
• MalfunctionNov 24, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2025, IN THE OPERATING ROOM, THE DOCTOR ENCOUNTERED A BENT PUNCTURE NEEDLE TIP DURING A LUMBAR EXTERNAL DRAINAGE PROCEDURE, RESULTING IN PUNCTURE FAILURE. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT TWICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631503 ↗
• MalfunctionNov 21, 2025Complete Blockage; Component Missing; Infusion or Flow Problem; Complete Blockage; Component Missing; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE PATIENT REQUIRED CONTINUOUS LUMBAR CISTERN DRAINAGE TO CLEAR CEREBROSPINAL FLUID AND PREVENT HYDROCEPHALUS DUE TO INTRAVENTRICULAR HEMORRHAGE. THEREFORE, ON (B)(6) 2025, A LUMBAR CISTERN DRAINAGE PROCEDURE WAS PERFORMED UNDER LOCAL ANESTHESIA. DURING THE PUNCTURE, IT WAS FOUND THAT THERE WAS NO GUIDEWIRE INSIDE THE DRAINAGE TUBE, AND NO EXTERNAL DRAINAGE BOTTLE WAS ATTACHED. AS A RESULT, IT WAS NOT POSSIBLE TO MONITOR THE PATIENT'S INTRACRANIAL PRESSURE OR CONTROL THE CEREBROSPINAL FLUID DRIP RATE. THIS RESULTED IN POOR DRAINAGE FROM THE LUMBAR CISTERN, WHICH WAS NOT DETECTED IN TIME AND ULTIMATELY LED TO CATHETER BLOCKAGE. A NEW DEVICE WAS USED INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23615825 ↗
• MalfunctionNov 21, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DURING THE CATHETERIZATION PROCEDURE, A RUPTURE WAS FOUND AT THE DISTAL END OF THE LUMBAR CISTERN DRAINAGE TUBE, WHICH RESULTED IN THE CEREBROSPINAL FLUID BEING UNABLE TO DRAIN PROPERLY. THE DEVICE WAS REPLACED WITH A NEW ONE. THERE WAS A PROCEDURE DELAY OF 20 MINUTES. THE PATIENT'S MEDICAL HISTORY WAS HYPERTENSION AND INFECTIOUS DISEASES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23615587 ↗
• MalfunctionNov 14, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2025, IN THE OPERATING ROOM, THE DOCTOR ENCOUNTERED A BENT PUNCTURE NEEDLE TIP DURING A LUMBAR-SACRAL PUNCTURE PROCEDURE, WHICH PREVENTED FURTHER OPERATION. THE SURGERY WAS COMPLETED AFTER REPLACING IT WITH A NEW DEVICE OF THE SAME MODEL. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554802 ↗
• InjuryNov 13, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2025, BEFORE THE PATIENT UNDERWENT CRANIOPLASTY, INTRACRANIAL PRESSURE NEEDED TO BE REDUCED USING A LUMBAR EXTERNAL DRAINAGE AND MONITORING SYSTEM. AFTER DECOMPRESSION WAS COMPLETED, THE LUMBAR EXTERNAL DRAINAGE AND MONITORING SYSTEM NEEDED TO BE REMOVED. DURING THE REMOVAL PROCESS, THE DOCTOR FOUND THAT THE DRAINAGE TUBE, WHICH SHOULD HAVE BEEN COMPLETELY REMOVED, BROKE, LEAVING ABOUT A 15 CM SEGMENT INSIDE THE PATIENT'S BODY, WHICH COULD NOT BE REMOVED BY CONVENTIONAL MEANS. AFTER COMMUNICATION WITH THE PATIENT'S FAMILY, THE SURGICAL TEAM DECIDED TO SURGICALLY OPEN THE SITE TO RETRIEVE THE REMAINING PART OF THE LUMBAR EXTERNAL DRAINAGE AND MONITORING SYSTEM. POSTOPERATIVELY, THE PATIENT WAS RETURNED TO THE WARD FOR FURTHER WOUND OBSERVATION. IN THIS EVENT, DUE TO BREAKAGE OF THE DRAINAGE DEVICE, A SURGICAL INCISION WAS REQUIRED AT THE PLACEMENT SITE TO REMOVE THE REMAINING SEGMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544663 ↗
• MalfunctionOct 27, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ABOUT TEN DAYS AFTER THE O OPERATION, THE TUBE BROKE. THE HOSPITAL DOCTOR INDICATED THAT THE TUBE HAD BEEN REMOVED, AND SYMPTOMATIC TREATMENT WAS GIVEN AFTERWARDS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390338 ↗
• MalfunctionOct 23, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2025, LUMBAR CISTERN DRAINAGE CATHETERIZATION WAS PERFORMED UNDER LOCAL ANESTHESIA AT THE WAIST. AFTER THE PROCEDURE, THE LUMBAR CISTERN DRAINAGE TUBE WAS SECURELY FIXED. ACCORDING TO MEDICAL ORDERS, THE HEIGHT OF THE LUMBAR CISTERN DRAINAGE TUBE WAS ADJUSTED TO 10¿15 CM ABOVE THE EXTERNAL AUDITORY CANAL, AND THE DAILY DRAINAGE VOLUME WAS CONTROLLED AT 150¿200 ML. THE PATIENT HAD LEFT UPPER LIMB MUSCLE STRENGTH OF GRADE 4 AND WAS CONTINUOUSLY RESTRAINED WITH A WAVE BOARD AND GLOVES. THE RIGHT UPPER LIMB MUSCLE STRENGTH WAS GRADE 1. FROM OCTOBER 18 TO 19, 2025, A TOTAL OF 176 ML OF LIGHT RED CEREBROSPINAL FLUID WAS DRAINED IN 24 HOURS. ON (B)(6) 2025, DURING THE SHIFT HANDOVER, IT WAS FOUND THAT THE LUMBAR CISTERN DRAINAGE TUBE HAD FRACTURED, AND NO CEREBROSPINAL FLUID WAS OBSERVED DRAINING FROM THE TUBE. THE RESPONSIBLE PHYSICIAN AND HEAD NURSE WERE IMMEDIATELY NOTIFIED. THE ORIGINAL PRODUCT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367136 ↗
• MalfunctionSep 19, 2025Break; Fracture; Insufficient Device Problem Information; Break; Fracture; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT WHILE PERFORMING A LUMBAR PUNCTURE DRAINAGE PROCEDURE IN THE OPERATING, THE DOCTOR USED THE DEVICE FOR LUMBOSACRAL PUNCTURE. DURING THE PROCEDURE, THE PUNCTURE NEEDLE FAILED TO PUNCTURE SUCCESSFULLY, RESULTING IN CATHETER BREAKAGE. A BACK UP PRODUCT OF THE SAME MODEL WAS USED, ALLOWING THE SURGERY TO PROCEED SMOOTHLY. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23094539 ↗
• MalfunctionSep 16, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE PATIENT WAS BEDRIDDEN AND, DUE TO THE CONDITION, HAD A LUMBAR CISTERN DRAINAGE DEVICE PLACED ON (B)(6) 2025. ON (B)(6) 2025, THE NURSE WAS MAKING ROUNDS AND NOTICED A SMALL WET AREA ON THE RIGHT SIDE OF THE PATIENT¿S BED. UPON INSPECTION, IT WAS FOUND THAT THE CONNECTOR AT THE DISTAL END OF THE LUMBAR CISTERN DRAINAGE TUBE HAD SPONTANEOUSLY DETACHED, AND CEREBROSPINAL FLUID WAS OBSERVED LEAKING FROM THE END OF THE TUBE. THE END OF THE TUBE WAS IMMEDIATELY FOLDED BACK, AND THE PHYSICIAN WAS NOTIFIED. THE DOCTOR REMOVED THE LUMBAR CISTERN DRAINAGE TUBE AND CLOSELY MONITORED THE PATIENT¿S VITAL SIGNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064531 ↗