MAUDE Adverse Event Report: OSCOR INC. LEAD ADAPTOR; PACEMAKER LEAD ADAPTOR

Model Number BIS/BIS-40

Device Problems High impedance (1291); Over-Sensing (1438); Ambient Noise Problem (2877)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/02/2019

Event Type  malfunction  

Manufacturer Narrative

Our investigation is still in progress ,follow up report will be submitted if we find any further additional information.

Event Description

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.

Manufacturer Narrative

The following sections were updated in follow-up.The device was in use for treatment and remains implanted.The device was not returned for analysis,therefore the clinical observation could not be confirmed.The investigation will focus on a review of product documentation.The device history records were reviewed to confirm that the device passed all applicable in process and final inspections.Per bipolar is -1 receptacle assembliy in-process & final inspection procedure, devices are inspected 100% as follows: 9.Electrical/mechanical inspection: check electrical continuity by using multimeter.Attach the red cable to the connector pin and black cable to the trokar needle.Insert trokar needle straight on the screw head through the seal of the connector pin receptacle on both legs and check for resistance.Nsert trokar needle into the other screw for connector hull receptacle to assure that there is no electrical connection/short.Attach red cable to the connector hull and follow the same method as above for the connector hull receptacles on both legs.Per instructions for use, (ifu), bis/bis adaptor: the adaptors are implanted in the extremely hostile environment of the human body.Because the adaptors are very small in diameter and must be very flexible, it inevitably reduces their potential performance and longevity.Adaptors may fail to function for a variety of causes, including medical complications, body rejection phenomenon, allergic reaction, fibrotic tissue problem, or a failure of adaptor by damage, fracture, or by breach of their insulation.Despite of all due care in design, component quality, manufacture and testing prior to sale, adaptors may be damaged by improper handling, use, placement or other intervening facts.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.In addition, there was no new failure mode identified and the risk remains acceptable.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.Oscor inc.Is submitting the above report to comply with 21 cfr part 803, the medical device reporting regulation.The report is based upon information obtained by oscor inc.Which the company may not have been able to investigate or verify prior to the date the report was required by fda.This report does not constitute an admission that the device, oscor inc., or its employees, caused or contributed to the event described in this report.Nor does this report reflect a conclusion by fda, oscor inc., or its employees, that the report constitutes an admission that the device, oscor inc., or its employees caused or contributed to the event described in this report.

Event Description

As per additional information revision surgery was schedule on 9th april 2019 because of noise and impedance rise.There was no other issue with adaptor biw07451.Adaptor remains in use.No further issues observed.

• Brand Name: LEAD ADAPTOR
• Type of Device: PACEMAKER LEAD ADAPTOR
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• MDR Report Key: 8582370
• MDR Text Key: 144141328
• Report Number: 1035166-2019-00038
• Device Sequence Number: 1
• Product Code: DTD
• UDI-Device Identifier: 00885672008369
• UDI-Public: 00885672008369
• Combination Product (y/n): N
• PMA/PMN Number: K010787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Model Number: BIS/BIS-40
• Device Catalogue Number: BIS/BIS-40
• Device Lot Number: C4-13629
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention