FDA.reportPublic FDA data

MAUDE MDR 417630

MDR report key
417630
Report number
1530440-2002-00011
Event key
0
Event type
3
Date of event
2002-06-28
Date received
2002-09-20
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 CORP.GZCUNKNANAYRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12002-09-2001. R

Event Narratives#

D

Patient 1

IN 2002, A CLINICIAN SUBMITTED A REQUEST FOR REPLACEMENT FREEHAND SYSTEM COMPONENTS. HOWEVER, THE REASON FOR THIS REQUEST WAS UNCLEAR AND DID NOT RESASONABLY SUGGEST THAT AN MDR REPORTABLE EVENT HAD OCCURRED. CLARIFICATION WAS REQUESTED AND, ON 08/21/2002, IT WAS DETERMINED THAT THIS PT MAY HAVE A FREEHAND IMPLANTED EPIMYSIAL ELECTRODE THAT HAS MALFUNCTIONED. THE CLINICIAN REPORTED THAT THIS PT ROUTINELY PLACES THEIR FOREARM ON THE EDGE OF A TABLE TO WRITE, WHICH MAY HAVE CUT THE INSULATION OF THIS ELECTRODE LEAD. TESTING IS REQUIRED TO DETERMINE THE ACTUAL MALFUNCTION. A REVISION SURGERY TO REPLACE THE ELECTRODE WILL BE REQUIRED TO RESTORE DEVICE FUNCTION. THE IDENTITY OF THIS PT AND ALL RELATED INFO (DATE OF BIRTH, SEX, DATE OF IMPLANT, SPECIFIC DEVICE IDENTIFICATION, ETC). ARE UNKNOWN AT THIS TIME, BUT A FOLLOW-UP REPORT WILL BE SUMBITTED WHEN THIS INFO IS AVAILABLE. ALSO A FOLLOW-UP REPORT WILL BE SUBMITTED FOLLOWING A REVISION SURGERY.