FDA.reportPublic FDA data

MAUDE MDR 2307510

MDR report key
2307510
Report number
1028232-2011-02425
Event key
0
Event type
3
Date of event
2011-08-29
Date received
2011-10-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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
1DEXTRUS 4136PACER LEADBIOTRONIK SE & CO. KGNVZ360310360310R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-10-1901. O

Event Narratives#

D

Patient 1

BOSTON SCIENTIFIC RECEIVED INFO THAT DURING THE PROCEDURE, AN ELECTROCAUTERY SCALPEL WAS USED WITHOUT NOTICING A MODE CHANGE. THIS RIGHT VENTRICULAR LEAD DISPLAYED INCREASED THRESHOLD MEASUREMENTS. A REVIEW OF THE ARRHYTHMIA LOGBOOK REVEALED NO EPISODES. THEREFORE, IT WAS THOUGHT THIS WAS UNRELATED TO THE ELECTROCAUTERY. IN ADDITION, LOSS OF CAPTURE WAS NOTED. REPROGRAMMING THE PACING CONFIGURATION DID NOT RESOLVE THE ISSUE. AN XRAY REVEALED THE LEAD HAD DISLODGED. THE DEVICE WAS REPROGRAMMED FROM DDD TO AAI PACING MODE. NO ADVERSE PT EFFECTS WERE REPORTED. ACCORDING TO AVAILABLE INFO, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. SHOULD ADD'L INFO BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

N

Patient 1

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE, BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE. THE MFG PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MFG PROCESS WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MFG.