FDA.reportPublic FDA data

MAUDE MDR 4054466

MDR report key
4054466
Report number
2017865-2014-09009
Event key
0
Event type
3
Date of event
2012-10-19
Date received
2014-01-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
CARY LAWLER
Address
15900 VALLEY VIEW CT. SYLMAR CA 91342 US
Phone
818-818-8184
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TENDRIL STSPERMANENT PACEMAKER ELECTRODEST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISIDTS2088TC/58SMTFY999Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-01-150

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT DURING IMPLANT THE RIGHT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE, INTERMITTENT SENSING, HIGH PACING THRESHOLD, AND HIGH IMPEDANCE. THE CONNECTOR PIN WAS OBSERVED TO BE BENT AND THE HELIX DID NOT EXTEND. THE LEAD WAS NOT IMPLANTED AND RETURNED.

N

Patient 1

ALL INFO PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.