FDA.reportPublic FDA data

MAUDE MDR 7533649

MDR report key
7533649
Report number
MW5077351
Event key
0
Event type
3
Date of event
2018-05-17
Date received
2018-05-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
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
1ALIVECOR KARDIABANDELECTROCARDIOGRAPHALIVECOR, INC.DPSAC-011-42-AKARDIABAND - 42MMI N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-05-210

Event Narratives#

D

Patient 1

UPON CALLING CUSTOMER SERVICE AT ALIVCOR BECAUSE THEIR KARDIA WATCH WAS NOT WORKING (IT WOULD NOT RECORD MY EKG), I WAS ASKED IF I HAD A HEARING AID OR A PACEMAKER. I HAVE A PACEMAKER PERMANENTLY IMPLANTED. I WAS THEN INFORMED THAT THE KARDIABAND WOULD NOT WORK WITH SUCH AN IMPLANTED DEVICE. I LOOKED ONLINE, FOUND THEIR INSTRUCTIONS FOR USE, AND IT WAS ONLY THEN THAT I READ THE WARNING THAT THE DEVICE SHOULD NOT BE USED IF YOU HAVE A PACEMAKER. THESE IFU'S ARE INADEQUATE, AS IT REQUIRES THE USER TO HAVE ACCESS TO THE ONLINE IFU'S. WARNINGS LIKE THESE SHOULD BE PRINTED AND FURNISHED WITH THE PRODUCT LABELING. THE COMPANY'S ONLINE ADVERTISING IS FALSE AND MISLEADING IN THAT NOWHERE DO THEY STATE IN THEIR COMPATIBILITY" CLAIMS THAT THE DEVICE CANNOT BE USED IN PTS WITH HEARING AIDS OR IMPLANTED DEVICES FOR CARDIAC RHYTHM, OR TO EVEN REFER TO THE INSTRUCTIONS FOR USE FOR ALL WARNINGS, PRECAUTIONS, INDICATIONS OR CONTRAINDICATIONS.