LUMBAR EXTENSION MACHINE
Received Dec 23, 2005 · Event occurred Dec 1, 2003
Report 1051095-2005-00001 · MDR key 656330
Device
Generic name
Measuring Exercise Device
Manufacturer
MedxModel number
MEDX LUMBARCatalog number
LU53
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Pain
Narrative
Description of Event or Problem
PATIENT ALLEGES HE WAS INJURED ON LUMBAR EXTENSION MACHINE CLAIMING THE MACHINE IMPROPERLY EXERTED FORCE ON HIS BODY CAUSING SERIOUS ORTHOPEDIC AND NEUROLOGICAL INJURY. ACCORDING TO HIS DOCTOR, THE PT BEGAN LUMBAR REHABILITATION USING THE LU53 MACHINE IN 2003 AND RESPONDED FAVORABLY. HE HAD SEVERAL SESSIONS FOR 21 DAYS WITH SUBSTANTIAL IMPROVEMENT NOTED ON FOLLOW UP TESTING IN 2003. ON SAME DAY, AFTER THE TESTING AND DURING THE DYNAMIC PORTION OF HIS REHABILITATION SESSION, THE PT WAS MOVING TOO FAST AND IGNORED DIRECTION TO SLOW DOWN. AFTER THE FIFTH REPETITION THE PATIENT EXPERIENCED AN ACUTE SHARP/SHOOTING PAIN IN HIS LEFT LUMBO-SACRAL/SIJ REGION WITH IMMEDIATE ATTENDANT LEFT LOWER EXTREMITY PAIN EXTENDING TO JUST BELOW THE LEVEL OF THE KNEE.
Remedial action
- Patient Monitoring