DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR 7122Q/58 7122Q-58

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR 7122Q/58 7122Q-58 manufactured by Abbott.

Event Text Entries

[185937006] This product is registered as a combination product. 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


[185937007] It was reported that the device delivered inappropriate high voltage therapy due to noise on the right ventricular (rv) lead. It was determined that the noise was caused by dislodgement of the rv lead. The rv lead was explanted and replaced to resolve the event. The patient was stable following the procedure and there were no adverse consequences.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2938836-2020-02370
MDR Report Key9908344
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-17
Date Mfgr Received2020-03-17
Device Manufacturer Date2018-03-21
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 G1ABBOTT
Manufacturer Street645 ALMANOR AVENUE
Manufacturer CitySUNNYVALE CA 94085
Manufacturer CountryUS
Manufacturer Postal Code94085
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 Number7122Q/58
Catalog Number7122Q-58
Lot NumberS000058310
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerABBOTT
Manufacturer Address645 ALMANOR AVENUE SUNNYVALE CA 94085 US 94085


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-31

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