FDA.reportPublic FDA data

MAUDE MDR 5011248

MDR report key
5011248
Report number
MW5055473
Event key
0
Event type
3
Date of event
2015-08-08
Date received
2015-08-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SOARIANMDDS/EHRSIEMENSNSXN *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-08-1201. H; 2. L; 3. R

Event Narratives#

D

Patient 1

THERE WAS TREATMENT FOR END STAGE HEART FAILURE THAT INCLUDED POTASSIUM SPARING DIURETICS, POTASSIUM SUPPLEMENTS, AND OTHER MEDICATIONS LISTED ON HEART FAILURE THERAPY GUIDELINES. INITIALLY, THERE WAS SYNCOPE WITH VENTRICULAR TACHYCARDIA WHILE THE POTASSIUM WAS LESS THAN NORMAL. IT WAS NOT UNTIL 24 HOURS AFTER A POTASSIUM TEST RESULT WAS COMPLETED THAT WAS 6 MEQ/L ( UP FROM 5 MEQ/L ONE DAY EARLIER) THAT ANYONE NOTICED THIS LIFE THREATENING METABOLIC PROBLEM. THE TREATMENT AND MEDICATION ADJUSTMENTS RESULTED IN A PROLONGED HOSPITALIZATION. THE FAILURE OF THE DEVICE TO WARN OF NEW RESULTS RENDERS THE EHR MDDS NOT UNLIKE A HEART MONITOR, THAT REQUIRES CHRONIC VIGILANCE TO AVOID MISSING A CRITICAL ARRHYTHMIA. THE EHR MDDS GENERALLY HAS ZERO VIGILANCE.