MAUDE Adverse Event Report: MEDTRONIC, INC. SELECTSECURE MRI SURESCAN; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV)

Model Number 3830

Device Problems Failure to Capture (1081); Crack (1135); Capturing Problem (2891); Impedance Problem (2950); Material Deformation (2976)

Patient Problems Dyspnea (1816); Fatigue (1849)

Event Date 10/08/2022

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.The event only occurred with one patient but specific details on the patient were not provided.The model listed in the report is a representative of the model family, as there is no specific model or lead length listed.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: lead-to-lead interaction leading to left bundle branch area pacing lead failure.Heart rhythm case reports.2023; 9(2):72¿75.Pmid: 36860748 doi: 10.1016/j.Hrcr.2022.10.007.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Literature was reviewed regarding lead-to-lead interaction with a left bundle branch area pacing (lbbap) lead.The authors described a patient who underwent an lbbap implant.Approximately twenty months post implant, the patient presented to the clinic with dyspnea on exertion and fatigue.The lbbap lead exhibited an acute rise in impedance and threshold with a loss of capture.A decision was made to explant and replace the lead.Preprocedural cinefluoroscopy of the system revealed lead-lead interaction with the defibrillator coil sliding against the lbbap lead near the ring electrode.Fluoroscopic images showed a sharp bend in the lbbap lead where the defibrillator coil appeared to make contact.The lbbap lead was explanted and replaced.Inspection of the extracted lbbap lead showed a break in insulation and conductor where the lead was in contact with the defibrillator coil.Detailed analysis of the lead showed wear and tear through the outer insulation, outer coil, ethylene-tetrafluoroethylene on the tip conductor, and the tip conductor.The source of the lead abrasion was determined to be the defibrillator coil as the lbbap lead body continuously rubbed against it, which resulted in progressive abrasion and lead failure.No additional adverse patient effects or product performance issues were reported.

• Brand Name: SELECTSECURE MRI SURESCAN
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV)
• 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: 16919219
• MDR Text Key: 315090010
• Report Number: 2182208-2023-01355
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3830
• Device Catalogue Number: 3830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2023
• 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
• Treatment: UNKNOWN ICD, 5076 LEAD, 6947 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male