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

Model Number	6207BTK-1
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that, whilst attempting to implant the pacing leads, the introducer kinked as the patient anatomy was tortuous around the superior vena cava (svc) and up to the right atrium.After the lead was successfully implanted, the lead dislodged as the introducer was being peeled off.The leads were re-positioned and the introducer was upsized.The lead remains implanted.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was further reported that only the right ventricular (rv) lead dislodged.

• 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: 9218010
• Report Number: 2182208-2019-01887
• Device Sequence Number: 2157350
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2021
• Device Model Number: 6207BTK-1
• Device Catalogue Number: 6207BTK-1
• Device Lot Number: W4681493
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR