N/A 27303 (UDI 00763000343200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00763000343200), received between Jul 29, 2022 and Sep 30, 2026 — classified as 5 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break; Fracture

  Medtronic received information regarding an external drainage and monitoring system. It was reported that on (b)(6) 2026, the patient had traumatic cerebral hemorrhage and altered consciousness, and lumbar cistern drainage was planned. During use of the lumbar drainage device, the drainage catheter broke intraoperatively, which might have delayed the surgery and increased the surgical risk. The procedure was immediately suspended, the site was disinfected and covered with sterile gauze, and a lumbar CT scan was promptly performed to guide treatment. After the position of the distal catheter segment was confirmed, lumbar foreign-body removal and lumbar cistern catheterization and drainage were performed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946272 ↗
• MalfunctionJun 16, 2026Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT SURGERY FOR A SELLAR REGION TUMOR. INTRAOPERATIVELY, CEREBROSPINAL FLUID LEAKAGE OCCURRED, AND A LUMBAR POND DRAINAGE DEVICE WAS PLACED POSTOPERATIVELY. DURING DRAINAGE, THE TUBE FRACTURED, LEAVING SEVERAL CENTIMETERS OF THE CATHETER RETAINED IN THE BODY. IT WAS SUSPECTED THAT A CUTTING EFFECT BETWEEN THE DRAINAGE TUBE AND THE PUNCTURE NEEDLE HAD CAUSED THE FRACTURE. THE INCIDENT WAS REPORTED TO THE SENIOR PHYSICIAN AND THE DEPARTMENT DIRECTOR, AND THE SITUATION WAS COMMUNICATED TRUTHFULLY WITH THE PATIENT¿S FAMILY. BASED ON DEPARTMENTAL DISCUSSION, CLINICAL EXPERIENCE, AND CONSIDERATION THAT SURGICAL REMOVAL WOULD INVOLVE SIGNIFICANT TRAUMA, AS WELL AS CONSULTATION WITH THE MANUFACTURER, AND GIVEN THAT THE RETAINED CATHETER SEGMENT HAD NOT CAUSED ANY DISCOMFORT TO THE PATIENT, A COMPREHENSIVE EVALUATION LED TO THE DECISION NOT TO SURGICALLY REMOVE THE RETAINED FRAGMENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25518200 ↗
• MalfunctionJun 11, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT FLUID LEAKAGE WAS DISCOVERED INTRA-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25473128 ↗
• MalfunctionMay 14, 2026Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT WHEN USING THE LUMBAR CISTERN DRAINAGE SYSTEM, IT WAS FOUND THAT THE CEREBROSPINAL FLUID COULD NOT BE DRAINED WHEN ATTEMPTING TO RELEASE IT INTO THE BAG. THE DEVICE WAS REPLACED WITH A NEW ONE. THERE WAS PROCEDURE DELAY OF 30 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 25172863 ↗
• InjuryMay 11, 2026Break; Complete Blockage; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT TO PROMOTE HEALING OF THE POSTERIOR OCCIPITAL MIDLINE INCISION (CEREBROSPINAL FLUID LEAKAGE FROM THE POSTERIOR MIDLINE INCISION AFTER VENTRICULAR DRAINAGE TUBE REMOVAL), CONSENT WAS OBTAINED FROM THE PATIENT¿S FAMILY, AND A CISTERNAL DRAINAGE PROCEDURE WAS PERFORMED IN THE GENERAL WARD. THE PATIENT WAS PLACED IN THE LEFT LATERAL KNEE-FLEXED POSITION. ROUTINE DISINFECTION AND DRAPING WERE PERFORMED. THE L2/3 INTERVERTEBRAL SPACE WAS SELECTED AS THE PUNCTURE SITE. AFTER SUCCESSFUL LOCAL INFILTRATION ANESTHESIA WITH 2% LIDOCAINE, THE LUMBAR PUNCTURE NEEDLE WAS INSERTED VERTICALLY THROUGH THE SKIN TO A DEPTH OF APPROXIMATELY 7 CM. THE STYLET WAS REMOVED, AND CLEAR, COLORLESS CEREBROSPINAL FLUID FLOWED OUT. THE PRESSURE WAS MEASURED AT 180 MMH2O. THE LUMBAR PUNCTURE NEEDLE WAS REMOVED. THE EXTERNAL DRAINAGE SYSTEM WAS OPENED, AND THE PUNCTURE NEEDLE WAS INSERTED ALONG THE ORIGINAL PUNCTURE SITE AND DIRECTION TO A DEPTH OF APPROXIMATELY 7 CM. AFTER REMOVING THE STYLET, CEREBROSPINAL FLUID WAS OBSERVED TO FLOW OUT. THE CISTERNAL DRAINAGE CATHETER WAS INSERTED THROUGH THE PUNCTURE NEED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136616 ↗
• MalfunctionJan 15, 2026Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON THE EVENING OF (B)(6) 2026, THE NURSE NOTICED FLUID LEAKAGE BELOW THE THREE-WAY CONNECTOR OF THE PATIENT'S LUMBAR POND DRAINAGE DEVICE. UPON EXAMINATION BY THE PHYSICIAN, A CRACK IN THE THREE-WAY TUBE WAS IDENTIFIED, WHICH CAUSED THE DRAINAGE FLUID TO LEAK. THE THREE-WAY CONNECTOR WAS IMMEDIATELY REPLACED, AND IODINE DISINFECTION WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24080179 ↗
• MalfunctionJan 12, 2026Break; Fracture; Difficult to Insert

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DURING THE LUMBAR CISTERN PUNCTURE DRAINAGE, THE TIP OF THE PUNCTURE NEEDLE LACKED SUFFICIENT HARDNESS, CAUSING IT TO BEND, TWIST, AND DEFORM, MAKING IT UNABLE TO PUNCTURE. THE DOCTOR USED TWO PUNCTURE NEEDLES, BOTH HAD BENT TIPS, MAKING NORMAL PUNCTURE AND INSERTION IMPOSSIBLE. A THIRD NEEDLE WAS USED AND WAS SUCCESSFULLY INSERTED. THERE WAS A PROCEDURE DELAY OF 30 MINUTES. THE PATIENT'S STATUS WAS ALIVE- NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037707 ↗
• MalfunctionDec 5, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE LUMBAR CATHETER SNAPPED UPON INSERTION AND WITHDRAWAL OF THE NEEDLE DURING A PERI-OPERATIVE LUMBAR DRAIN INSERTION. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23726626 ↗
• MalfunctionNov 4, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON SEPTEMBER 22, 2025, A LUMBAR CISTERN CATHETER WAS PLACED FOR THE PATIENT. ON OCTOBER 5, A RUPTURE WAS DISCOVERED IN THE EXTERNAL PORTION OF THE LUMBAR CISTERN DRAINAGE CATHETER AT THE PATIENT END. THE CATHETER WAS IMMEDIATELY REMOVED UPON DISCOVERY. BECAUSE IT WAS DETECTED IN TIME, NO ADVERSE EFFECTS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464993 ↗
• MalfunctionSep 16, 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, DURING THE PLACEMENT OF A LUMBAR CISTERN DRAINAGE DEVICE FOR THE PATIENT, THE PUNCTURE WAS SUCCESSFUL AND CEREBROSPINAL FLUID WAS DRAINED. HOWEVER, FLUID LEAKAGE WAS FOUND AT THE WHITE THIN TUBE OF THE LUMBAR PUNCTURE DRAINAGE DEVICE. THE ISSUE WAS ADDRESSED IMMEDIATELY. AFTER NORMAL FUNCTION WAS RESTORED, UPON ASSESSMENT OF THE CAUSE OF THE LEAKAGE, IT WAS FOUND THAT THE DISTAL TUBING WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066403 ↗
• MalfunctionJan 22, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR TREATMENT DUE TO RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM AND BLEEDING. AFTER ADMISSION, THE PATIENT UNDERWENT LUMBAR SUBARACHNOID SPACE INTUBATION DRAINAGE UNDER LOCAL ANESTHESIA ON (B)(6) 2024. DURING THE SURGERY, A TUBE WAS INSERTED INTO THE LUMBAR SUBARACHNOID SPACE. DURING THE INDWELLING PROCESS, IT WAS FOUND THAT THE THREE-WAY JOINT OF THE TUBE WAS BROKEN. THE DEVICE WAS REPLACED IMMEDIATELY. NO OBVIOUS HARM WAS CAUSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21208742 ↗
• InjuryNov 27, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE PATIENT HAD AN INTRACRANIAL ANEURYSM AND WAS SCHEDULED TO UNDERGO A CRANIOTOMY. A LUMBAR DRAINAGE TUBE WAS PLACED TO RELIEVE INTRACRANIAL PRESSURE AND FACILITATE THE SURGERY. AFTER THE SURGERY, BLOODY CEREBROSPINAL FLUID WAS DEPLOYED, ALLEVIATED THE PATIENT'S SYMPTOMS. LYING ON LEFT SIDE, WITH THE BACK PERPENDICULAR TO THE BED, BENT THE NECK AND HUGGED THE KNEES. SELECTED THE 4-5 LUMBAR INTERVERTEBRAL SPACE AS THE PUNCTURE POINT AND MARKED IT. USED THE LUMBAR EXTERNAL DRAINAGE AND MONITORING SYSTEM, ROUTINELY DISINFECTED THE SKIN, WORE STERILE GLOVES, AND SPREAD A STERILE HOLE TOWEL. FIXED THE PUNCTURE SKIN WITH LEFT HAND, HELD THE PUNCTURE NEEDLE WITH RIGHT HAND, PERPENDICULAR TO THE BACK, AND INSERTED THE NEEDLE TIP SLIGHTLY OBLIQUELY TOWARD THE HEAD ALONG THE PUNCTURE POINT. AFTER THE RESISTANCE SUDDENLY DISAPPEARED AND THERE WAS A SENSE OF EMPTINESS, SLOWLY WITHDREW THE NEEDLE CORE, AND LIGHT RED BLOODY CEREBROSPINAL FLUID COULD BE SEEN FLOWING OUT. INSERTED THE DRAINAGE TUBE, CONNECTED THE DRAINAGE TUBE TO THE STERILE DRAINAGE BAG, AND AFTER LOCAL DISINFEC TION, COVERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20795769 ↗
• MalfunctionSep 16, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DURING USE, LEAKAGE WAS FOUND AT THE JOINT. THE DEVICE WAS REPLACED WITH A NEW ONE IMMEDIATELY. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20223496 ↗
• MalfunctionSep 3, 2024Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORT THAT AFTER THE SURGERY, A DRAINAGE TUBE WAS PLACED, HOWEVER, THE TUBE BECAME BLOCKED WITHIN A DAY AND COULD NOT BE USED. AFTER SEVERAL ATTEMPTS, THE DRAINAGE WAS UNSUCCESSFUL. IT WAS FURTHER STATED THAT THE TUBE WAS BLOCKED AND SUCTION COULD NOT BE PERFORMED; AFTER WITHDRAWAL, SUCTION COULD NOT BE PERFORMED. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20125358 ↗
• MalfunctionMay 28, 2024Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DURING THE PREPARATION FOR SURGERY, THE OUTER PACKAGING OF THE DEVICE WAS OPENED. THE SURGEON USED AN EMPTY NEEDLE TO PUSH PHYSIOLOGICAL SALINE INTO THE WHITE LUMBAR EXTERNAL DRAINAGE CATHETER. HOWEVER, THE NORMAL SALINE COULD NOT BE PUSHED IN, AND IT WAS FOUND THAT THE DRAINAGE CATHETER WAS BLOCKED. THE DEVICE WAS IMMEDIATELY REPLACED TO COMPLETE THE SURGICAL TREATMENT. THERE WAS A 20 MINUTE DELAY IN THE PROCEDURE. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19404277 ↗
• MalfunctionMay 22, 2024Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT WAS PUSHED INTO THE OPERATING ROOM TO PREPARE FOR LUMBAR SURGERY UNDER LOCAL ANESTHESIA. DURING SURGICAL PREPARATION PROCESS, THE OUTER PACKAGING OF THE LUMBAR EXTERNAL DRAINAGE AND MONITORING SYSTEM WAS OPENED, AND THE SURGEON USED AN EMPTY NEEDLE TO PUSH NORMAL SALINE INTO THE WHITE LUMBAR EXTERNAL DRAINAGE CATHETER. HOWEVER, THE NORMAL SALINE COULD NOT BE PUSHED IN, AND IT WAS FOUND THAT THE DRAINAGE CATHETER WAS BLOCKED. IT WAS IMMEDIATELY REPLACED WITH A NEW SET OF EXTERNAL LUMBAR DRAINAGE AND MONITORING SYSTEM TO COMPLETE THE SURGICAL TREATMENT FOR THE PATIENT. THERE WAS A DELAY IN THE OPERATION TIME DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19369817 ↗
• MalfunctionMay 10, 2024Break; Fracture; Component Missing; Break; Fracture; Component Missing

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE PRODUCT WAS DAMAGED FROM THE MANUFACTURER. THE RESIDENT DESCRIBED THE TIP ON THE CATHETER AS BEING FRACTURED. THE PRODUCT WAS ALSO MISSING THE DRAINAGE CAPSULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19285478 ↗
• MalfunctionMay 8, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM FOR DRAINING CEREBROSPINAL FLUID IN THE SUBARACHNOID SPACE OF THE WAIST. IT WAS REPORTED THAT BEFORE USE, THE OUTER PACKAGING WAS CHECKED. THE PACKAGING WAS INTACT, NOT DAMAGED, NO VISIBLE CONTAMINATION INSIDE, AND COULD BE USED NORMALLY. ON (B)(6) 2024, THE NURSE CHECKED THE COLLECTION OF THE FLUID COLLECTION BAG ACCORDING TO THE DOCTOR'S INSTRUCTION. WHEN THE FLUID COLLECTION BAG WAS LIFTED, THE INTEGRATED LUER CONNECTOR OF THE LUMBAR EXTERNAL DRAINAGE AND MONITORING SYSTEM BROKE. THE DOCTOR REPLACED WITH A NEW EXTERNAL DRAINAGE AND MONITORING SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19268202 ↗
• MalfunctionMay 8, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM FOR DRAINING CEREBROSPINAL FLUID IN THE SUBARACHNOID SPACE OF THE WAIST. IT WAS REPORTED THAT BEFORE USE, THE OUTER PACKAGING WAS CHECKED. THE PACKAGING WAS INTACT, NOT DAMAGED, NO VISIBLE CONTAMINATION INSIDE, AND COULD BE USED NORMALLY. ON APRIL 12, 2024, THE CONSUMABLE CONNECTOR BROKE WHEN THE DOCTOR USED IODOPHOR TO DISINFECT THE CONNECTOR OF THE LUMBAR EXTERNAL DRAINAGE AND MONITORING SYSTEM. THE OPERATION PROCESS WAS GENTLE AND DID NOT SQUEEZE THE CONSUMABLES. THE DOCTOR REPLACED WITH A NEW EXTERNAL DRAINAGE AND MONITORING SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19267983 ↗
• MalfunctionFeb 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXTERNAL LUMBAR DRAINAGE ON (B)(6) 2024, AND LIQUID LEAKAGE FROM THE THREE-WAY VALVE OCCURRED 3 DAYS AFTER THE SURGERY. THE DEVICE WAS REPLACED WITH A NEW ONE TO PREVENT RETROGRADE INFECTION. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738336 ↗
• MalfunctionJan 8, 2024Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT DURING THE POST-OPERATIVE CARE, IT WAS DISCOVERED THAT THE THREE-WAY OF THE EXTERNAL EXTENSION TUBE WAS BROKEN AND LEAKING LIQUID. THE DEVICE WAS REPLACED WITH A SPARE ONE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464542 ↗
• MalfunctionJan 2, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE SYSTEM. IT WAS REPORTED THAT AFTER OPENING THE PACKAGE, IT WAS FOUND THAT THE PRODUCT WAS BROKEN AT THE LUMBAR END CATHETER. THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18428477 ↗
• InjuryDec 28, 2023Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE SYSTEM. IT WAS REPORTED THAT WHEN PERFORMING A LUMBAR EXTERNAL DRAINAGE SYSTEM ON A PATIENT. AFTER PUNCTURE, THE HEALTH CARE PROFESSIONAL (HCP) FOUND THAT THE CONNECTION POINT OF THE LUMBAR EXTERNAL DRAINAGE CATHETER WAS DETACHED AND DAMAGED, AND CEREBROSPINAL FLUID WAS LEAKING. THE HCP CONSIDERED IT A PRODUCT QUALITY PROBLEM AND REQUESTED REPLACEMENT. THE PROCEDURE WAS COMPLETED WITH A NEW EXTERNAL DRAINAGE SYSTEM. NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18408688 ↗
• MalfunctionNov 3, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE PATIENT SUFFERED FROM INCISIONAL CEREBROSPINAL FLUID LEAKAGE AFTER FACIAL NERVE MICROVASCULAR DECOMPRESSION. A LUMBAR DRAINAGE WAS PLACED ON (B)(6) 2023, TO CONTINUOUSLY RELEASE CEREBROSPINAL FLUID AND PROMOTE HEALING OF CEREBROSPINAL FLUID LEAKAGE COMBINE. ON (B)(6) 2023, IT WAS DISCOVERED THAT THE CONNECTION SITE OF THE LUMBAR DRAINAGE TUBE HAD FALLEN OFF AND CEREBROSPINAL FLUID WAS LEAKING, SO IT WAS IMMEDIATELY CLOSED. IT WAS ASSESSED THAT CEREBROSPINAL FLUID DRAINAGE STILL NEEDED TO BE CONTINUED FOR 5-7 DAYS, AND THE LUMBAR DRAINAGE TUBE WAS REPLACED ON (B)(6) 2023. THE LUMBAR DRAINAGE TUBE CONTINUED TO BE KEPT UNOBSTRUCTED AND CEREBROSPINAL FLUID WAS CONTINUOUSLY DRAINED TO PROMOTE THE HEALING OF THE OCCIPITAL INCISION. DUE TO TIMELY DISCOVERY AND TREATMENT, NO ACTUAL HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066439 ↗
• InjuryOct 26, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT ON (B)(6) 2023, WHEN THE DOCTOR PLACED THE TUBE IN THE LUMBAR CISTERN FOR THE PATIENT IN THE OPERATING ROOM ACCORDING TO THE NORMAL OPERATION PROCESS, THE DRAINAGE TUBE OF THE LUMBAR CISTERN BROKE AND REMAINED IN THE PATIENT'S BODY. AFTER INFORMING THE PATIENT'S FAMILY IN DETAIL AND OBTAINING THEIR CONSENT, THE SOFT TISSUE AT THE LUMBAR TUBE INSERTION SITE WAS INCISED TO SEARCH FOR THE STUMP OF THE LUMBAR CISTERN DRAINAGE TUBE. UNABLE TO FIND THE STUMP, THE STUMP OF THE LUMBAR CISTERN DRAINAGE TUBE WAS LEFT IN THE PATIENT'S BODY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18011132 ↗