FDA.reportPublic FDA data

MAUDE MDR 2018677

MDR report key
2018677
Report number
1644243-2011-00006
Event key
0
Event type
3
Date of event
2011-12-01
Date received
2011-03-04
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
TIMOTHY JOHNSON
Address
14401 S.E. FIRST ST. VANCOUVER WA 98684 US
Phone
360-360-3608
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RS-OA KNEE SYSTEMTRANSCUTANEOUS KNEE NERVE/MUSCLE STIM.RS MEDICALNYNRS-OAY N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-03-0401. O

Event Narratives#

D

Patient 1

PT CLAIMS USE OF THE RS-OA KNEE SYSTEM STIMULATOR INTERFERED WITH IMPLANTED CARDIAC PACEMAKER RESULTING IN TRANSIENT HEART RATE CHANGES. PT WAS USING THE STIMULATOR FOR THEIR INITIAL TREATMENT BUT SUSPENDED THE TREATMENT AFTER A FEW MINUTES WHEN HEART RATE CHANGES WAS OBSERVED. PT SAID THE IMPLANTED PACEMAKER WAS AFFECTED BY THE KNEE STIMULATION TREATMENT. PT DID NOT SUFFER ANY FURTHER EFFECTS OR ANY INJURY. PT CONSULTED WITH HIS CARDIOLOGIST, DID NOT USE THE STIMULATOR FURTHER AND RETURNED THE KNEE STIMULATOR SYSTEM.

N

Patient 1

RS-OA KNEE STIMULATOR HAS BEEN RETURNED AND MET ALL APPLICABLE QUALITY ASSURANCE CRITERIA AND SPECIFICATIONS. RS-OA OPERATION MANUAL CONTRAINDICATIONS SPECIFY "DO NOT USE THE DEVICE IF YOU ARE A CARDIAC DEMAND PACEMAKER." PRESCRIBING PHYSICIAN IS (B)(6).