MAUDE Adverse Event Report: OSCOR INC. BIS/IS-15; PACEMAKER LEAD ADAPTOR

Model Number	BIS/IS-15
Medical Device Problem Codes	Over-Sensing (1438); Device Sensing Problem (2917); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported right ventricular (rv) lead in left ventricular (lr) port 2 5071 adapted into bipolar config had chronic high thresholds and poor sensing.Lv lead in rv port 4968 had oversensing in bipolar and pause was observed on holter with reproducible oversensing with isometrics and movement.Reprogrammed to uni with 4 mv sensitivity and resolved some of the oversensing and inhibition.Revision/new case scheduled.Discussed extraction not recommended on epi leads.Referred to oma if doctor would like to discuss extraction further.Discussed possible configuration options to try and get better sensing.Consider switching leads back to port where they are placed and testing multiple configurations.Patient is pacer dependent.The adaptor remains in the patient.
Additional Manufacturer Narrative
The following sections were updated in follow-up 1.B4, g3, g6, h2, h10 the report received from the customer was sent to oscor in error.There was no allegation against an oscor product; therefore, this report is being voided.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.

• Brand Name: BIS/IS-15
• Common Device Name: PACEMAKER LEAD ADAPTOR
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer Contact: doug myers ; 3816 desoto blvd.; palm harbor, FL 34683-1816 ; 7279372511
• MDR Report Key: 12982817
• Report Number: 1035166-2021-00152
• Device Sequence Number: 5302241
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2021
• Device Model Number: BIS/IS-15
• Device Catalogue Number: BIS/IS-15
• Device Lot Number: C4-13720
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown