MAUDE Adverse Event Report: MEDTRONIC, INC. SOLOTRAK KR PERCUTANEOUS LEAD INTRODUCER; INTRODUCER, CATHETER

Model Number	6207BTK-1
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	12/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient experienced perforation during the implant procedure.It was reported that the right atrial (ra) lead was on the contralateral side of the superior vena cava (svc) and had protruded into the chest cavity, which was confirmed by x-ray and computerized tomography (ct).The patient was transferred with introducers in place and emergency hemostasis was performed.The introducer was explanted and the ra lead was explanted and replaced under general anesthesia.No further patient complications have been reported as a result of this event.

• Brand Name: SOLOTRAK KR PERCUTANEOUS LEAD INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 11229990
• Report Number: 2182208-2021-00371
• Device Sequence Number: 3795103
• Product Code: DYB
• UDI-Device Identifier: 00681490142939
• UDI-Public: 00681490142939
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K911236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2021
• Device Model Number: 6207BTK-1
• Device Catalogue Number: 6207BTK-1
• Device Lot Number: W4945662
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 01/26/2021
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 79 YR