DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR 7120Q/58 7120Q-58

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR 7120Q/58 7120Q-58 manufactured by St. Jude Medical, Inc.(crm-sylmar).

Event Text Entries

[185931044] This product is registered as a combination product. Further information was requested but was not available. The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10


[185931045] It was reported that noise resulting in non sustained right ventricular oversensing, aborted shocks and low pacing impedance was observed on the right ventricular lead. The patient felt a jolt but it didn't appear to have been from a shock. Th patient was pending further.
Patient Sequence No: 1, Text Type: D, B5


[186731556] Further information was requested but was not yet received.
Patient Sequence No: 1, Text Type: N, H10


[186731557] New information received notes further testing revealed noise with isometric testing. The patient subsequently received one inappropriate shock. Right ventricular capture thresholds were increased and r waves were diminished. The patient was brought in for a procedure for downgrade due to the noise. The right ventricular lead was capped (b)(6) 2020 and replaced.
Patient Sequence No: 1, Text Type: D, B5


[188600027] Should include the patient was stable following the procedure.
Patient Sequence No: 1, Text Type: N, H10


[188600028] The patient's status was noted as stable following the procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2017865-2020-04469
MDR Report Key9908244
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-12
Date Mfgr Received2020-03-13
Device Manufacturer Date2010-09-28
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactELIZABETH BOLTZ
Manufacturer Street15900 VALLEY VIEW COURT
Manufacturer CitySYLMAR CA 91342
Manufacturer CountryUS
Manufacturer Postal91342
Manufacturer G1ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
Manufacturer Street15900 VALLEY VIEW COURT
Manufacturer CitySYLMAR CA 91342
Manufacturer CountryUS
Manufacturer Postal Code91342
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
Generic NameDEFIBRILLATION LEAD
Product CodeNVY
Date Received2020-03-31
Model Number7120Q/58
Catalog Number7120Q-58
Lot Number3220781
Device Expiration Date2011-09-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL, INC.(CRM-SYLMAR)
Manufacturer Address15900 VALLEY VIEW COURT SYLMAR CA 91342 US 91342


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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