MAUDE Adverse Event Report: OSCOR INC. BIS/BIS-40; PACEMAKER LEAD ADAPTOR

Model Number	BIS/BIS-40
Medical Device Problem Codes	High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned to oscor for evaluation.Oscor inc.Has no corrective action specific to this product.Without the return of the actual device in question for evaluation, oscor is unable to determine the exact cause for this incident, therefore, this complaint is non-verifiable.A review of the manufacturing processes indicates the production operators are instructed to 100% visually inspect for any obvious defect prior to shipment.At this time, it is not possible to assign a definitive root cause for the event as reported.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 th.
Event or Problem Description
It was reported the patient was scheduled for a pacemaker relocation procedure on (b)(6) 2023.Two extenders were used and tunneled the abdomen.At the end of procedure, measures were within normal limits.Right atrial (ra) lead impedance through device was 530-540 ohms with threshold of 0.5/0.4.On the morning of (b)(6) 2023, the ra impedance was 1126 ohms in bipolar and 837 ohms in unipolar.During the revision, the physician reset the connection involving the atrial lead and the extender in the left pectoral pocket.The implantable pulse generator (ipg), right atrial (ra) lead and extender remain in use.There was no procedure delay and no patient complications have been reported.

• Brand Name: BIS/BIS-40
• Common Device Name: PACEMAKER LEAD ADAPTOR
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34655
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer Contact: daniel naut ; 3816 desoto blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 17216229
• Report Number: 1035166-2023-00067
• Device Sequence Number: 3011341
• Product Code: DTD
• UDI-Device Identifier: 00885672008369
• UDI-Public: 00885672008369
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K010787
• 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
• Report Date (Section B): 06/28/2023

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: 12/01/2024
• Device Model Number: BIS/BIS-40
• Device Catalogue Number: BIS/BIS-40
• Device Lot Number: C4-15415
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown