UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEM
Report
- Report Number
- 9612164-2024-02064
- Event Type
- Injury
- Date Received
- April 30, 2024
- Date of Event
- October 13, 2023
- Report Date
- April 30, 2024
- Manufacturer
- MEDTRONIC MEXICO
- Product Code
- GWM
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEGAN DECK, HILARY P. GROCOTT, MICHAEL H. YAMASHITA. INTRATHECAL HEMATOMA AS A NEURAXIAL COMPLICATION OF LUMBAR CEREBROSPINAL FLUID DRAINAGE FOR ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM. CAN J ANESTH/J CAN ANESTH (2023) 70. DOI: 10.1007/S12630-023-02588-Y REPORTED EVENT: - HEREIN, WE DESCRIBE A 73-YR-OLD MALE (WHO CONSENTED TO THIS REPORT) WHO PRESENTED FOR AN ELECTIVE THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) OF A DESCENDING THORACIC AORTIC ANEURYSM AND CHRONIC STANFORD TYPE B AORTIC DISSECTION. HE WAS NOT RECEIVING ANY ANTIPLATELET OR ANTICOAGULANT AGENTS DURING THE WEEK PRIOR TO THE PROCEDURE AND HAD A NORMAL PREOPERATIVE COAGULATION PROFILE WITH AN INTERNATIONAL NORMALIZED RATIO OF 1.0 AND A PLATELET COUNT OF 171 X 10^9 L^¿1. ON THE DAY OF THE TEVAR, AND JUST PRIOR TO THE INDUCTION OF ANESTHESIA, A LUMBAR CSF DRAIN (EXACTATM EXTERNAL DRAINAGE AND MONITORING SYSTEM, MEDTRONIC, INC; MINNEAPOLIS, MN, USA) WAS INSERTED 15 CM INTO THE CSF SPACE THROUGH A SINGLE MIDLINE, ATRAUMATIC PUNCTURE WITH A 14G TUOHY EPIDURAL NEEDLE AT THE L3/4 INTERSPACE IN THE SITTING POSITION. INTRAVENOUS UNFRACTIONATED HEPARIN WAS ADMINISTERED INTRAOPERATIVELY TO TARGET AN ACTIVATED CLOTTING TIME OF 300 SEC. THE PROCEDURE PROCEEDED UNEVENTFULLY, THE HEPARIN EFFECT WAS REVERSED WITH PROTAMINE SULPHATE, AND THE PATIENT WAS EXTUBATED IN THE INTERVENTIONAL RADIOLOGY SUITE NEUROLOGICALLY INTACT PRIOR TO TRANSFER TO THE CARDIAC SURGICAL INTENSIVE CARE UNIT. ON POS TOPERATIVE DAY (POD) 1, THE LUMBAR DRAIN WAS FOUND TO BE NONFUNCTIONAL. AS THE PATIENT HAD NO NEUROLOGIC DEFICITS, AND AFTER CONFIRMATION OF NORMAL COAGULATION PARAMETERS, THE LUMBAR DRAIN WAS REMOVED. ON POD2, THE PATIENT DEVELOPED PAINLESS RIGHT LEG WEAKNESS CON CERNING FOR SPINAL CORD ISCHEMIA. SEVERAL ATTEMPTS WERE MADE TO REINSERT A LUMBAR DRAIN AS A RESCUE MANEUVER,BUT NO CSF COULD BE OBTAINED AFTER TWO ATTEMPTS. MAGNETIC RESONANCE IMAGING OF THE SPINE SHOWED A SIZABLE INTRATHECAL HEMATOMA EXTENDING FROM THE SECOND LUMBAR (L2) TO THE FIRST SACRAL VERTEBRAE (S1) ENVELOPING AND LIKELY COMPRESSING SOME OF THE DISTAL SPINAL NERVE ROOTS. A SPINE SURGERY SPECIALIST WAS CONSULTED AND RECOMMENDED CONSERVATIVE MANAGEMENT. THE PATIENT WAS TREATED WITH PHARMACOLOGIC AUGMENTATION OF THE MEAN ARTERIAL PRESSURE ([90MMHG) AND WITHIN 24 HR, HIS RIGHT LEG WEAKNESS COMPLETELY AND PERMANENTLY RESOLVED. THIS CASE WAS NOTABLE FOR THE RARELY DESCRIBED INTRATHECAL NATURE OF THE NEURAXIAL HEMATOMA AND THE ABSENCE OF ANY EXPECTED ARACHNOIDITIS-RELATED PAIN TYPICALLY SEEN WITH SUBARACHNOID BLEEDING. .
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2080755 | UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEM | DEVICE, MONITORING, INTRACRANIAL PRESSURE | GWM | MEDTRONIC MEXICO | UNKNOWN-E | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |