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

Model Number	BIS/BIS-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up report 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 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.
Event or Problem Description
It was reported that the patient experienced a pocket infection.The implantable pulse generator (ipg) system was explanted.No further patient complications have been reported as a result of this event.The customer reported the implant date of the adaptor is (b)(6) 2023 and the explant date is (b)(6) 2025.The adaptor will be returned.
Additional Manufacturer Narrative
The following sections were updated in follow-up 1.B4, d9, g3, g6, h2, h3, h6 & h11.One bis/bis-40 implantable adaptor was returned under rma# (b)(4).There were no other accessories.Traces of blood were found on and inside the adaptor.According to the event description summary, the ipg system including the adaptor was explanted due to infection and there were no product performance issues or complaints noted at the time of explant.The adaptor was returned in two pieces/halves and coils were protruding from the insulation.When examined under a microscope, there were no visible broken or fractured welds at the receptacle or connector ends.Per qa procedure (bipolar lead adaptors/extensions final inspection).Sample size: 100%.Check electrical resistance by using a multimeter and record the measurements on the device history record.Ifu was provided with this product.Returned device analysis revealed the adaptor was severed in half which was likely done during the explant procedure since it was reported no performance issue for the device, but no other anomalies were noted.Additionally, all parameters in the sterility report met the required specifications.Since the adaptor was severed in half, the electrical values could not be tested.In conclusion, the review of the dhr did not identify any manufacturing anomalies and passed all final testing prior to shipment.Based on available information a cause could not be established.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/BIS-40
• 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: ronnie greco ; 4875 palm harbor blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 22292346
• Report Number: 1035166-2025-00037
• Device Sequence Number: 18365852
• Product Code: DTD
• UDI-Device Identifier: 00836559003151
• UDI-Public: 00836559003151
• 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
• Device Implanted Year: 2023
• 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): 09/12/2025

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: Health Professional
• Device Expiration Date: 02/20/2026
• Device Model Number: BIS/BIS-40
• Device Catalogue Number: BIS/BIS-40
• Device Lot Number: C3-19286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown