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	06/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion not yet available-evaluation in progress.This initial mdr is being submitted to meet our requirements of reporting.A follow-up will be submitted as soon as the investigation is complete.
Event or Problem Description
This device was explanted on (b)(6) 2017 due to infection, however, it was reported an epicardial lead was abandoned surgically.This device will not be returned as the devices were disposed of.
Additional Manufacturer Narrative
The lead was not returned for analysis.It is part of a system explanted due to an infection.The lead has been actively implanted for approximately 7 years, 9 months and thus, considered to be associated with the reported infection.No allegation our device failed to meet its performance specifications or caused or contributed to the infection.Proof of sterilization is on file.The device history records and the complaint files of the device model were reviewed.No trend of the same or similar type was found or indicated.Infection is a recognized clinical event referenced in the device's labeling and/or reported in the medical literature.A review of risk for this failure mode identified the risk to be medium.Infection is a recognized clinical event referenced in the device's labeling and/or reported in the medical literature."as with the introduction of any foreign object into the body, an infection might result.Removal of the device may be required." oscor will continue to monitor this device for complaint trends and risk.The potential effect to patient for the reported failure may be related to: patient requires additional medical treatment.The potential cause(s) for the reported failure may be related to: device sterility compromised device not used by adequately trained personnel.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.Instructions for use (ifu), (unipolar/bipolar adaptor) oscor's medical devices meet all applicable federal regulations governing sterilization prior to being released from our facility.In addition, all of oscor's sterilized products have consistently passed biocompatibility tests prior to release in shipment.Based upon our testing of products sterilized in this manner, oscor is confident its products are safe for their intended use.The adaptors are implanted in the extremely hostile environment of the human body.Because the adaptors are very small in diameter and must be very flexible, it inevitably reduces their potential performance and longevity.Adaptors may fail to function for a variety of causes, including medical complications, body rejection phenomenon, allergic reaction, fibrotic tissue problem, or a failure of adaptor by damage, fracture, or by breach of their insulation.Despite all due care in design, component quality, manufacture and testing prior to sale, adaptors may be damaged by improper handling, use, placement or other intervening facts.

• 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
• MDR Report Key: 6761886
• Report Number: 1035166-2017-00068
• Device Sequence Number: 1490246
• Product Code: DTD
• UDI-Device Identifier: 00885672003692
• UDI-Public: 00885672003692
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K010787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2018

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: Physician
• Device Expiration Date: 01/01/2012
• Device Model Number: 4402
• Device Catalogue Number: 4402
• Device Lot Number: C2-10382
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/05/2017
• Supplement Date Received by Manufacturer: 07/05/2017
• Initial Report FDA Received Date: 08/02/2017
• Supplement Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention