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

Model Number	VV-PLUG
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device used in treatment.The device was not returned for analysis, as the device remains implanted.The device remains in service for approximately 1 years, 9 months since the (b)(6) 2021 event date.There was no device performance related failure reported by the user.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.No further investigation 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 will continue to monitor this event type and risk.
Event or Problem Description
It was reported that leads were explanted due to infection.There was no issue with vv-plug reported and vv-plug remains actively implanted.There was surgical intervention reported to explant the lead.No additional information available.No other serious injury reported.
Additional Manufacturer Narrative
Correction: h6 : correcting health effect - clinical code to 1930(unspecified infection).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: VV-PLUG
• Common Device Name: PACEMAKER LEAD ADAPTOR
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd; palm harbor FL 34683
• MDR Report Key: 11880821
• Report Number: 1035166-2021-00052
• Device Sequence Number: 3632820
• Product Code: DTD
• UDI-Device Identifier: 00885672008291
• UDI-Public: 00885672008291
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K031164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2021

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: 11/01/2021
• Device Model Number: VV-PLUG
• Device Catalogue Number: VV-PLUG
• Device Lot Number: C4-14016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 10/07/2021
• 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