FDA.reportPublic FDA data

MAUDE MDR 2739305

MDR report key
2739305
Report number
3005868392-2012-00001
Event key
0
Event type
3
Date of event
2012-07-29
Date received
2012-09-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
300 ARTINO STREET OBERLIN OH 44074 US
Phone
440-440-4407
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NEURX DIAPHRAGM PACING SYSTEMOIR DIAPHRAGMATIC/PHRENIC NERVE STIMULATORSYNAPSE BIOMEDICAL INC.HCC20-003520-0035-041712-10-8R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-09-0701. L; 2. R

Event Narratives#

D

Patient 1

THE PT IS A YOUNG MALE WHO SUSTAINED SEVERE CHEST INJURIES AND HAD BEEN ON POSITIVE-PRESSURE MECHANICAL VENTILATION FOR OVER 200 DAYS. A ONE-TIME IRB APPROVAL FOR AN OFF-LABEL USE WAS OBTAINED TO ATTEMPT TO STRENGTHEN THE PT'S DIAPHRAGM AND WEAN HIM OFF MECHANICAL VENTILATION. THE PT WAS USING THE DEVICE ON A NORMAL COURSE SINCE SURGICAL IMPLANTATION ON (B)(6) 2012. IN A ROUTINE CHECK FOR CARDIAC RHYTHM CAPTURE DURING THE SURGERY (PER THE INSTRUCTIONS FOR USE) PREMATURE VENTRICULAR CONTRACTIONS (PVCS) WERE DETECTED WITH THE DEVICE AT MAXIMUM STIMULATION SETTINGS. THE STIMULATION SETTINGS WERE ADJUSTED DOWN ACCORDINGLY AND THE PVCS WERE NO LONGER SEEN. OVER THE COURSE OF THE NEXT 20 DAYS THE DEVICE STIMULATION PARAMETERS WERE ADJUSTED TO RESOLVE PAIN ISSUES, DEAL WITH DIAPHRAGM FATIGUE, AND IMPROVE HYPOVENTILATION AT NIGHT. THIS DID INVOLVE INCREASING THE STIMULATION PARAMETERS ALTHOUGH NO PVCS OR VTACH WERE NOTED. ON (B)(6) 2012, APPROX 40 MINUTES AFTER THE DEVICE WAS TURNED ON FOR THE NIGHT, THE PT EXPERIENCED VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION. CPR WAS PERFORMED, CARDIOVERSION WAS DONE 3 TIMES, AND 1 MG OF EPINEPHRINE WAS ADMINISTERED TO RESTORE NORMAL RHYTHM. THE EPISODE LASTED 4 MINUTES. THE DEVICE WAS IN USE AT THE TIME OF THE INCIDENT. THE FACILITY CONSIDERED THE EVENT "SERIOUS" AND "POSSIBLY RELATED". IT CANNOT BE DEFINITIVELY DETERMINED WHETHER THE DEVICE CONTRIBUTED TO THE INCIDENT OR NOT. THE PT COMPLETELY RECOVERED AND HAS BEEN USING THE DEVICE SINCE THE INCIDENT AT LOWER STIMULATION SETTING WITHOUT RECURRENCE.

N

Patient 1

BECAUSE THIS WAS AN OFF-LABEL USE OF THE DEVICE AND A DECISION WAS MADE TO INCREASE THE STIMULATION PARAMETERS ALTHOUGH THERE WAS A PREVIOUSLY IDENTIFIED SUSCEPTIBILITY TO CARDIAC RHYTHM INTERFERENCE, WE DO NOT BELIEVE ANY FURTHER ACTION IS INDICATED IN RESPONSE TO THIS INCIDENT. THE INSTITUTION AND MEDICAL PROFESSIONALS INVOLVED FOLLOWED APPROPRIATE PROCEDURES FOR AN OFF-LABEL USE, INCLUDING APPROPRIATE PT MONITORING, IN AN ATTEMPT TO HELP THE PT WITH PREVIOUSLY UNSUCCESSFUL VENTILATORY WEANING. WE UNDERSTAND THAT THE PT HAS WEANED FROM MECHANICAL VENTILATION AND IS HEALTHY (PREVIOUS INJURIES NOT WITHSTANDING). THIS APPEARS TO BE A REASONABLE PRACTICE OF MEDICINE WITH RISKS APPROPRIATELY MANAGED AND THERE IS NO INDICATION OF A DEVICE MALFUNCTION.