FDA.reportPublic FDA data

MAUDE MDR 6794088

MDR report key
6794088
Report number
MW5071569
Event key
0
Event type
3
Date of event
2017-07-30
Date received
2017-08-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
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
1KENDALL DISPOSABLE LEAD SETCABLE, ELECTRODECARDINAL / COVIDIENIKD33136T33136T289267I Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-140

Event Narratives#

D

Patient 1

THE DISPOSABLE LEADS FROM KENDALL ON A PT HAD A DEFECT AND IT WAS SHOWING A POSTERIOR HEMI BLOCK, EKG WAS PERFORMED SHOWING SINUS RHYTHM WITH FIRST DEGREE BLOCK AS PER PREVIOUS EKG DONE IN ER. LEADS WERE CHANGED AND NO HARM WAS CAUSED . FIVE LEAD DUAL CONNECT DISPOSABLE LEAD SET. DATE OF USE (B)(6) 2017. DIAGNOSIS OR REASON FOR USE: ELEVATED HR 140 RANGE.