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

Model Number	C/IS-10 SS2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Our investigation is still in progress, follow up report will be submitted if we find any further additional information.
Event or Problem Description
It was reported that lead adaptors were explanted because of right ventricular lead infection.There was no known issue with adaptor reported.The patient's implant site is well healed with swelling that has improved.There are no signs of infection.The groin access site has no bruising with good pulse.No additional information is available.
Additional Manufacturer Narrative
The following sections were updated in follow-up.B4,g3,g6,h2,h6,h10.The device was used for treatment.The device was not returned.The adaptor was implanted for 2 months 21 day before being explanted on (b)(6) 2020 due to infection.The investigation was focus on the documentation review.The device history records were reviewed to confirm that the devices passed all applicable in process and final inspections.There was no product performance issue reported.As per ifu, infection is listed as possible complications of the device.As with the introduction of any foreign object into the body, an infection might result.Removal of the device may be required.No further investigation 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 will continue to monitor this event type and risk.No further follow-up is required.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: LEAD ADAPTOR
• Common Device Name: PACEMAKER LEAD ADAPTOR
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd; palm harbor FL 34683
• MDR Report Key: 11314804
• Report Number: 1035166-2021-00015
• Device Sequence Number: 3711526
• Product Code: DTD
• UDI-Device Identifier: 00885672008277
• UDI-Public: 00885672008277
• 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: 2020
• Device Explanted Year: 2020
• 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): 07/08/2021

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: 09/01/2022
• Device Model Number: C/IS-10 SS2
• Device Catalogue Number: C/IS-10 SS2
• Device Lot Number: C1-18042
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 07/08/2021
• 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: Required Intervention
• Patient Age: 75 YR