FDA.reportPublic FDA data

MAUDE MDR 340038

MDR report key
340038
Report number
1530440-2001-00022
Event key
0
Event type
3
Date of event
2001-05-29
Date received
2001-06-28
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
MICHAEL SOUTHWORTH
Address
8333 ROCKSIDE ROAD VALLEY VIEW OH 44125 US
Phone
216-216-2169
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FREEHAND SYSTEMHAND GRASP NEUROPROSTHESISNEUROCONTROL CORPGZC1060-1NANAP9500YRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12001-06-2801. O

Event Narratives#

D

Patient 1

A PT WAS IMPLANTED WITH THE FREEHAND SYSTEM HAND GRASP NEUROPROSTHESIS IN 1996. IN 2001, THE PT REPORTED THAT THE DEVICE WAS NOT OPERATING PROPERLY, AS THERE WAS NO HAND STIMULATION. ONE DAY AFTER EVENT DATE, THE EXTERNAL CONTROL UNIT WAS REPLACED AND SOME STIMULATION WAS RESTORED. HOWEVER, THE STIMULATION WAS INTERMITTENT AND DID NOT PRODUCE A GRASP. THE EXTERNAL SYSTEM COMPONENTS ARE BELIEVED TO BE FUNCTIONING PROPERLY, AND MALFUNCTION OF THE IMPLANTABLE RECEIVER - STIMULATOR IS SUSPECTED. ADDITIONAL TESTING IS BEING SCHEDULED. FOLLOW UP INFORMATION WILL BE PROVIDED WHEN AVAILABLE.