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

Model Number	6207-S1
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
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 during implant of a pacing lead the sheath of a introducer teared unevenly and didn't go inside the vein.The introducer was not used and was replaced. no patient complications have been reported as a result of this event.

• Brand Name: PERCUTANEOUS LEAD INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 12949384
• Report Number: 2182208-2021-04771
• Device Sequence Number: 4948383
• Product Code: DYB
• UDI-Device Identifier: 00681490143011
• UDI-Public: 00681490143011
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/07/2021

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: 07/27/2023
• Device Model Number: 6207-S1
• Device Catalogue Number: 6207-S1
• Device Lot Number: W6539686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/07/2021
• Date Device Manufactured: 07/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male