QUARTET 1458Q/86 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 2014-01-13 for QUARTET 1458Q/86 SMTFY999 manufactured by St. Jude Medical, Crmd.

Event Text Entries

[4796388] It was reported that during implant the physician saw blood inside the lead. When flushed with water a hole in the insulation was discovered. The lead was repaired with medical adhesive and remained implanted.
Patient Sequence No: 1, Text Type: D, B5


[12412211] 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 Number2017865-2014-07013
MDR Report Key4121386
Report Source01,05,06,07
Date Received2014-01-13
Date of Event2011-08-29
Date Facility Aware2011-08-29
Date Mfgr Received2011-08-29
Device Manufacturer Date2011-06-01
Date Added to Maude2014-10-03
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameQUARTET
Generic NamePERMANENT PACEMAKER ELECTRODE
Product CodeDTS
Date Received2014-01-13
Model Number1458Q/86
Catalog NumberSMTFY999
Device Expiration Date2014-06-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age2 MO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL, CRMD
Manufacturer Address15900 VALLEY VIEW CT. SYLMAR CA 91342 US 91342


Patients

Patient NumberTreatmentOutcomeDate
10 2014-01-13

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