LEAD ADAPTOR BIS/BIS-40

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-05-06 for LEAD ADAPTOR BIS/BIS-40 manufactured by Oscor Inc..

Event Text Entries

[144141328] Our investigation is still in progress ,follow up report will be submitted if we find any further additional information.
Patient Sequence No: 1, Text Type: N, H10


[144141329] It was reported that, overnight adaptor was attached to the atrial lead. In morning there was impedance spike to 3000 ohms uni/bip, 625 ohms sensing, 1. 5mv threshold 1. 0v @ 0. 4ms and noise noted. Patient was admitted for lead revision surgery, undertook provocation maneuvers and appeared to be at site of adapter. Surgical revision was performed on the left sided pocket and the adapter for atrial lead was inspected the distal set screw was loose, doctor retightened set screw and provocation maneuvers were done with no notable noise on the channel after fixing the set screw. No other additional information available and no other adverse event reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1035166-2019-00038
MDR Report Key8582370
Report SourceDISTRIBUTOR,FOREIGN
Date Received2019-05-06
Date of Report2019-05-21
Date of Event2019-04-02
Date Mfgr Received2019-05-07
Device Manufacturer Date2018-01-02
Date Added to Maude2019-05-06
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 ContactMR DOUG MYERS
Manufacturer Street3816 DESOTO BLVD
Manufacturer CityPALM HABROR FL 34683
Manufacturer CountryUS
Manufacturer Postal34683
Manufacturer Phone7279372511
Manufacturer G1OSCOR INC.
Manufacturer Street3816 DESOTO BLVD
Manufacturer CityPALM HABROR FL 34683
Manufacturer CountryUS
Manufacturer Postal Code34683
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEAD ADAPTOR
Generic NamePACEMAKER LEAD ADAPTOR
Product CodeDTD
Date Received2019-05-06
Model NumberBIS/BIS-40
Catalog NumberBIS/BIS-40
Lot NumberC4-13629
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOSCOR INC.
Manufacturer Address3816 DESOTO BLVD. PALM HARBOR FL 346831816 US 346831816


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-05-06

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