MAUDE Adverse Event Report: OSCOR INC. PACEMAKER LEAD ADAPTOR 4402

Model Number	4402
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/23/2021
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.
Event or Problem Description
It was reported that a (b)(6) male underwent a procedure for cardiac resynchronization therapy defibrillator (crt-d).Extraction was performed due to infection, however, it was reported that an epicardial lead appears to be abandoned.There was no known device issue reported.
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow up report will be submitted as soon as the investigation is complete.
Event or Problem Description
It was reported that a (b)(6) male underwent a procedure for cardiac resynchronization therapy defibrillator (crt-d).Extraction was performed due to infection, however, it was reported that an epicardial lead appears to be abandoned.There was no known device issue reported.
Additional Manufacturer Narrative
The following sections were updated in follow-up 1.B4, g3, g6, h2, h4, h6, h10.The device was in service for approximately 13 years, 1 month before being explanted on (b)(6) 2021.The lead was not returned for analysis.It is part of a system explanted due to an infection.No allegation our device failed to meet its performance specifications or caused or contributed to the infection.Infection is a recognized clinical event referenced in the device's labeling and/or reported in the medical literature.The device history records could not be reviewed, however, inspection procedures require any oscor product pass all in-process and qa final inspection before shipping to the customer.Quality assurance procedure final labeling/packaging inspection of all products: all labeling and packaging will be inspected one hundred percent (100%).Sealed areas (tyvek lid to lip of tray and breather bag) are continuous around entire perimeter of tray.No voids, breaks, and or bubbles along the seal.The entire seal should be at least quarter inch wide and have a full ridge.The tyvek pull tab must be properly folded into position.Examine the seal and border for uniformity of the seal.Check for holes or any other damages that could violate sterility.Ensure tray and breather bag is properly sealed.No further follow-up is required.Based on the investigation, a capa is not required as there was no issue reported for the device performance or quality.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: PACEMAKER LEAD ADAPTOR 4402
• 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: 13579782
• Report Number: 1035166-2022-00027
• Device Sequence Number: 5731091
• Product Code: DTD
• UDI-Device Identifier: 00885672003692
• UDI-Public: 00885672003692
• 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
• Device Implanted Year: 2008
• Device Explanted Year: 2021
• 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): 06/27/2022

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 Model Number: 4402
• Device Catalogue Number: 4402
• Device Lot Number: C2-09108
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2007
• 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: Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male