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

Model Number 6207-S1

Device Problems Accessory Incompatible (1004); Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the implant procedure, the introducer was very soft and did not give good support.It was further reported that it was not easy to manipulate the pacing lead that passed through the introducer.It was also reported that the introducer was damaged, crushed and perforated.The introducer was replaced.The pacing lead remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that the pacing lead was positioned in the right ventricle.

• Brand Name: PERCUTANEOUS LEAD INTRODUCER
• Type of Device: 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: 10078703
• MDR Text Key: 191685874
• Report Number: 2182208-2020-00932
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00681490143011
• UDI-Public: 00681490143011
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K911236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2022
• Device Model Number: 6207-S1
• Device Catalogue Number: 6207-S1
• Device Lot Number: W5104066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2020
• Date Device Manufactured: 01/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 90 YR
• Patient Weight: 70