TENDRIL STS 2088TC/58 SMTFY999

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2014-01-15 for TENDRIL STS 2088TC/58 SMTFY999 manufactured by St. Jude Medicla, Inc., Crmd.

Event Text Entries

[4807231] It was reported that the right ventricular lead exhibited high impedance and threshold during implant. The lead was explanted and replaced.
Patient Sequence No: 1, Text Type: D, B5


[11918431] All information provided by manufacturer, 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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2017865-2014-09129
MDR Report Key4054563
Report Source01,05,06,07
Date Received2014-01-15
Date of Event2012-08-11
Date Facility Aware2012-08-11
Date Mfgr Received2012-09-24
Device Manufacturer Date2012-06-01
Date Added to Maude2014-09-08
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 FDA0
Event Location3
Manufacturer ContactCARY LAWLER
Manufacturer Street15900 VALLEY VIEW CT.
Manufacturer CitySYLMAR CA 91342
Manufacturer CountryUS
Manufacturer Postal91342
Manufacturer Phone8184932621
Manufacturer G1ST JUDE MEDICAL, INC.
Manufacturer Street15900 VALLEY VIEW CT.
Manufacturer CitySYLMAR CA 91342
Manufacturer CountryUS
Manufacturer Postal Code91342
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTENDRIL STS
Generic NamePERMANENT PACEMAKER ELECTRODE, DTS
Product CodeDTS
Date Received2014-01-15
Model Number2088TC/58
Catalog NumberSMTFY999
Device Expiration Date2015-06-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age2 MO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICLA, INC., CRMD
Manufacturer Address15900 VALLEY VIEW CT. SYLMAR CA 91342 US 91342


Patients

Patient NumberTreatmentOutcomeDate
10 2014-01-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.