FDA.reportPublic FDA data

MAUDE MDR 2860321

MDR report key
2860321
Report number
1028232-2012-02917
Event key
0
Event type
3
Date of event
2012-11-12
Date received
2012-11-21
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#

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 53PACER LEADBIOTRONIK SE & CO. KGNVN350974SEE MODEL NO.R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-11-2101. H

Event Narratives#

D

Patient 1

UPON ROUTINE FOLLOW-UP, PATIENT HAD A MODE SWITCH EPISODE THAT OCCURRED ON (B)(6) 2012 THAT SHOWED NOISE ON BOTH THE FF AND ATRIAL CHANNELS ONLY. UNABLE TO REPRODUCE THE NOISE WITH ANY PROVOCATIVE TESTING OR PALPATION OF THE POCKET. LEAD IMPEDANCES, SENSING AND THRESHOLDS ARE ALL STABLE AND UNCHANGED SINCE IMPLANT WHICH WAS ON (B)(6) 2010. DEVICE AND LEAD WILL CONTINUE TO BE MONITORED AT THIS TIME. ON (B)(4) 2012- AS OF TODAY, ALL AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS OBTAINED, THIS EVENT WILL BE UPDATED.

N

Patient 1

THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.