MAUDE Adverse Event Report: MPRI CAPSUREFIX NOVUS LEAD MRI SURESCAN; PERMANENT PACEMAKER ELECTRODE

Model Number 5076-52

Device Problems Coagulation in Device or Device Ingredient (1096); Mechanical Problem (1384); Use of Device Problem (1670); Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Pocket Erosion (2013); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2023

Event Type  Injury  

Event Description

It was reported that the patient experienced pocket erosion and wound dehiscence approximately one month post implant of a right atrial (ra) lead and a right ventricular (rv) lead, which were connected to an existing implantable pulse generator (ipg).It was reported that the ipg system was exposed to the air and was contaminated but not necessarily infected.The ipg system was explanted and the pocket was debriefed, respected and closed to prevent any future infection.A leadless ipg was then attempted to be implanted in the rv septum.It was reported that intra-operative, the leadless ipg system was caught in previously capped leads.It was reported that there were possible tissue and blood clots between the device and the cup of the delivery system, and the ipg was unable to be retracted into the cup despite flushing.It was also reported that delivery system was bent.The leadless ipg system was attempted/not used and was replaced.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Continuation of d10: product id: 4092-58 lead, implanted: (b)(6) 2004; product id: 4592-53 lead, implanted: (b)(6) 2004; product id: mc1avr1 ipg, implanted: (b)(6) 2023; product id w3dr01 ipg implanted: (b)(6) 2021; product id: 5076-58, implanted: (b)(6) 2023.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CAPSUREFIX NOVUS LEAD MRI SURESCAN
• 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: 18510798
• MDR Text Key: 332877526
• Report Number: 2649622-2024-01317
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 00643169633759
• UDI-Public: 00643169633759
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P930039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5076-52
• Device Catalogue Number: 5076-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2023
• Date Device Manufactured: 05/23/2023
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male