FDA.reportPublic FDA data

MAUDE MDR 2343142

MDR report key
2343142
Report number
3004733458-2011-00001
Event key
0
Event type
3
Date of event
2011-10-18
Date received
2011-11-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MR SCOTT SIMCOX
Address
907 SOUTH LAKEWOOD AVE. BALTIMORE MD 21224 US
Phone
800-800-8006
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RT300-SLFES CYCLE ERGOMETERRESTORATIVE THERAPIES INC.GZIFA100052IN212372Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-11-1701. H

Event Narratives#

D

Patient 1

PATIENT HAS CONGENITAL NEUROMUSCULAR HYPOTONIA AND CONGENITAL HEART APLASIA. PATIENT WAS CYCLING WHEN THE SYSTEM REPORTED A "PAD OFF" ERROR ON MULTIPLE CHANNELS. THE MOTHER OF THE PATIENT THEN REPORTED THAT HER SON HAD A SPASM IN HIS LOWER EXTREMITIES. SHORTLY AFTERWARDS HE REQUESTED OXYGEN BECAUSE HE HAD DIFFICULTY BREATHING (PATIENT HAS LOW CONGENITAL NEUROMUSCULAR HYPOTONIA AND CONGENITAL HEART APLASIA). PATIENT WAS HOSPITALIZED FOR ONE WEEK WHILE O2 SATS REMAINED LOW. DURING HOSPITALIZATION PHYSICIANS FOUND NOTHING WRONG WITH HIM AFTER EXTENSIVE WORK-UP.

N

Patient 1

EVALUATED THE STIMULATION CABLE AND DISCOVERED A FRAYED CONDUCTOR IN CONTACT WITH THE CONDUCTOR OF ANOTHER WIRE WITHIN THE CABLE CAUSING A SHORT CIRCUIT CONDITION. MODIFIED CONTROLLER SOFTWARE TO DETECT ANY CABLE FAULTS BEFORE STIMULATION IS APPLIED TO THE ELECTRODES. EVALUATED CONTROLLER SOFTWARE MODIFICATION. VALIDATION REPORT IDENTIFIED ALL SHORT CIRCUIT CONDITIONS; TWO STIMULATING ELECTRODES IN CONTACT, STIMULATING ELECTRODE IN CONTACT WITH GROUND, NON-STIMULATING ELECTRODE IN CONTACT WITH GROUND, ETC. RESULT IN A "PAD-OFF" ERROR WITH A BRIEF (