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

Model Number	BIS/BIS-40
Medical Device Problem Codes	Ambient Noise Problem (2877); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up will be submitted as soon as the investigation is complete.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 have not 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 or Problem Description
Per customer, we received the following information and portions of myopore bp35, model 360882 and oscor is-1 adaptor (b)(6) (serial number portion received).Event occurred in us.No patient death, harm, or injury was reported.On (b)(6) 2025 the patient's dual chamber pacemaker was explanted and upgraded to a cardiac resynchronization therapy pacemaker.The chronic myopore right ventricular lead would have been reused but was being explanted due to noise and sensing issues.During the procedure, the oscor is-1 adaptor was seen on fluoroscopy and was also removed, it is unknown if it played a part in the reported issues.The chronic myopore right ventricular lead, and oscor adaptor, were successfully explanted at cleveland clinic main campus.During same procedure, a new medtronic epicardial right ventricular lead was successfully implanted.We have no pictures, images, or videos to share.

• Brand Name: OSCOR LEAD ADAPTOR
• Common Device Name: PACEMAKER LEAD ADAPTOR
• Manufacturer (Section D): OSCOR INC.; 4875 palm harbor blvd.; palm harbor FL 34683
• Manufacturer (Section G): OSCOR INC.; 4875 palm harbor blvd.; palm harbor FL 34683
• Manufacturer Contact: mohit malkani ; 4875 palm harbor blvd; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 23622610
• Report Number: 1035166-2025-00057
• Device Sequence Number: 9032336
• Product Code: DTD
• UDI-Device Identifier: 00885672008369
• UDI-Public: 00885672008369
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K010787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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): 07/08/2026

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: 06/01/2026
• Device Model Number: BIS/BIS-40
• Device Catalogue Number: BIS/BIS-40
• Device Lot Number: C3-19551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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 Age: 37 YR
• Patient Sex: Unknown