InjuryGWM
NEURO MONITORING DEVICE
Received Oct 8, 2019 · Event occurred Jan 5, 2015
Report MW5090314 · MDR key 9172893
Device
Generic name
Device, Monitoring, Intracranial Pressure
Manufacturer
UnkProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
52 YR
- Paralysis
- Weakness
- Numbness
- Ambulation or Postural Difficulties
- Vascular System (Circulation), Impaired
- Paralysis
- Weakness
- Numbness
- Ambulation or Postural Difficulties
- Vascular System (Circulation), Impaired
Narrative
Description of Event or Problem
I HAD A SPINAL FUSION AT L4-L5. THE RESTRAINT STRAPS ON THE JACKSON TABLE HAVE LEFT BOTH MY LEGS ON THE FRONT ONLY COMPLETELY NUMB FROM 5 INCHES ABOVE MY KNEES TO 5 INCHES BELOW MY KNEES. THE STRAPS PERMANENTLY CUT OFF THE CIRCULATION, NEARLY 5 YEARS AGO AND NO IMPROVEMENT. ALSO DURING SAME SURGERY THE NEURO-MONITORING FAILED TO SHOW ANY SIGNS OF NERVE DAMAGE, HOWEVER I WOKE UP PARALYZED. IT TOOK 4 MONTHS TO LEARN TO WALK AGAIN. STILL VERY WEAK LEGS. THIS TEST CONFIRMED NERVE DAMAGE WHERE I HAVE NUMBNESS AND WEAKNESS. FDA SAFETY REPORT ID # (B)(4).