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

Model Number	BIS/IS-15
Medical Device Problem Code	High Sensing Threshold (2574)
Health Effect - Clinical Codes	Syncope (1610); Chest Pain (1776); Dizziness (2194); Palpitations (2467)
Date of Event	02/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested, however not received as of date of this report.Conclusion not yet available as the investigation is on-going.
Event or Problem Description
It was reported that the right ventricular (rv) lead had high thresholds.The patient experienced recurrence of dizziness and near syncope last month.The rv capture thresholds were increased to the highest outputs, which resolved the symptoms.It was noted that the patient continues to experience occasional palpitations and squeezing chest pain.During the procedure, two left ventricular (lv) leads were attempted, but not used due to no superior capture threshold and in most locations no capture at all.The physician decided to use the alternative rv epicardial lead, with stable thresholds to give the patient more than five years of pacing.The lead is still in use.No further patient complications have been reported as a result of this event.Additional information has been requested but not provided.
Additional Manufacturer Narrative
The device was in use for treatment.The device was not returned for analysis.The device history record was reviewed to confirm that the device passed all applicable in-process and final inspections.The investigation will focus on a review of product documentation.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity and no new failure mode identified.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type.Per procedure unipolar and bifurcated bipolar lead adaptors/extensions and lead extension with universal coupler final inspection : the setscrew is checked by qa 100% both visually and with a torque wrench to ensure smooth functionality.The electrical values are checked by qa 100% as well.Per instructions for use (ifu) : product awareness: 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.

• Brand Name: BIPOLAR LEAD ADAPTOR
• Common Device Name: PACEMAKER LEAD ADAPTOR
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• MDR Report Key: 7453888
• Report Number: 1035166-2018-00033
• Device Sequence Number: 1575587
• Product Code: DTD
• UDI-Device Identifier: 00836559002680
• UDI-Public: 00836559002680
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K925168
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 06/01/2019
• Device Model Number: BIS/IS-15
• Device Catalogue Number: BIS/IS-15
• Device Lot Number: C4-12976
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 09/13/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention