MAUDE Adverse Event Report: MPRI SCREW-IN LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 5071-35

Device Problem Connection Problem (2900)

Patient Problem Scar Tissue (2060)

Event Date 10/06/2022

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 5076-85 lead, implanted: (b)(6) 2015.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

The patient reported that, approximately three months post generator and epicardial left ventricular (lv) lead changeout, they experienced, "too much," scar tissue formed due to, "so many," surgeries and interfered with the implantable pulse generator (ipg) system connectivity.The ipg system remains in use. no further patient complications have been reported as a result of this event.

• Brand Name: SCREW-IN LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 15678703
• MDR Text Key: 306751295
• Report Number: 2649622-2022-21631
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 00643169638594
• UDI-Public: 00643169638594
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5071-35
• Device Catalogue Number: 5071-35
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2022
• Date Device Manufactured: 01/31/2022
• 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
• Treatment: W1DR01 IPG.
• Patient Age: 47 YR
• Patient Sex: Female