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

Model Number BIS/IS-15

Device Problems Failure to Capture (1081); Device Sensing Problem (2917); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2022

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 there was no capture at maximum output (7.5v @ 1.5ms) and the only sensed r waves were from the external pacemaker.During the implantable icd interrogation, we turned off the external pacer in order to ascertain the underlying rhythm, and it was discovered the patient's rhythm was complete heart block.The doctor then turned the external pacer back on to maintain capture.Subsequently, he successfully inserted a temporary transvenous wire and connected it to the external temporary pacemaker, where constant capture was taking place.Patient outcome is stable.No additional information is available.

Manufacturer Narrative

The following sections were updated in follow-up 1: b1,b2, b4, g1, g3, g6, h2, h6, h10 and h11.Correction : b1,b2,h6 :there was no issue with bis/is-15 adaptor reported.The epicardial lead was not capturing and the patient was very symptomatic.Thus, b1,b2, h6 updated accordingly.There was no issue with bis/is-15 adaptor reported.The adaptor was not returned and remains implanted since the event date 3/15/2022.The investigation was focused 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 no further investigation is required.Based on the investigation, a capa is not required.The event will be re-evaluated if additional information becomes available.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
• Type of Device: 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
• Manufacturer Contact: doug myers ; 3816 desoto blvd; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 14407179
• MDR Text Key: 291742405
• Report Number: 1035166-2022-00065
• Device Sequence Number: 1
• Product Code: DTD
• UDI-Device Identifier: 00836559002680
• UDI-Public: 00836559002680
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BIS/IS-15
• Device Catalogue Number: BIS/IS-15
• Device Lot Number: C4-15262
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male