FDA.reportPublic FDA data

MAUDE MDR 2410963

MDR report key
2410963
Report number
1028232-2012-00005
Event key
0
Event type
3
Date of event
2011-12-15
Date received
2012-01-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
6024 JEAN ROAD LAKE OSWEGO OR 97035 US
Phone
877-877-8772
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SETROX S 60PACER LEADBIOTRONIC SE & CO., KG.NVZ350975350975* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-01-0601. H

Event Narratives#

D

Patient 1

THIS PT HAS EBSTEIN'S ANOMALY AND REQUIRED A LEAD REPOSITIONING. INCREASED THRESHOLDS WERE NOTED THE DAY FOLLOWING IMPLANTED. A MICRODISLODGEMENT WAS SUSPECTED. ALL RECORDS INDICATE THIS LEAD REMAINS ACTIVELY IMPLANTED. SHOULD ADD'L INFO BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.