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 report with the FDA on 2019-02-19 for LEAD ADAPTOR BIS/BIS-40 manufactured by Oscor Inc..

Event Text Entries

[136595837] Our investigation is still in progress, follow up report will be submitted if we found any further additional information.
Patient Sequence No: 1, Text Type: N, H10


[136595838] It was reported that, implanting physician had to regain axillary venous access to place a lead 5076-85 ((b)(4)) which was then tunneled to the abdomen. Physician removed the already implanted 3830-59 because of both adaptors failed and lead could not be tunneled to the pocket and connected to an abdominal icd. This 3830 lead was then to be extended and tunneled to the abdomen where it was to be connected to an icd. Because of the adapter issue physician choose to remove the 3830 lead and placed 5076-85 lead and tunnel to the abdominal pocket. On both adaptor, the distal setscrew could not be engaged with a wrench kit to tighten the screw. Physician had to cut silicone away to be able to engage the screw. Upon attempts to engage the screw, the screw would not lock down on the terminal pin of the lead - the screw spun incessantly. Eventually leading to stripping of the screw. At a couple moments the screw just fell out of the adaptor port. Re-engaging the screw was challenging. First adaptor was connected to the device where electrically checked okay but then became very noisy. Physician try to attempt second adapter. There was no patient complication reported. There was delay in surgery about 1. 5-2 hours because of adapter tinkering. No additional information is available. For second adaptor see mdr 1035166-2019-00010.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1035166-2019-00009
MDR Report Key8351768
Report SourceDISTRIBUTOR
Date Received2019-02-19
Date of Report2019-05-02
Date of Event2019-01-02
Date Mfgr Received2019-04-29
Device Manufacturer Date2017-03-29
Date Added to Maude2019-02-19
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 HARBOR FL 346831816
Manufacturer CountryUS
Manufacturer Postal Code346831816
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEAD ADAPTOR
Generic NamePACEMAKER LEAD ADAPTOR
Product CodeDTD
Date Received2019-02-19
Model NumberBIS/BIS-40
Catalog NumberBIS/BIS-40
Lot NumberC4-13317
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOSCOR INC.
Manufacturer Address3816 DESOTO BLVD PALM HARBOR FL 34683 US 34683


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-02-19

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