MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL CONSULTA CRT-P; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	C4TR01
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that the patient experienced chest pressure and shortness of breath.  it was also reported that during use of the right atrial (ra) lead atrial events appeared to be falling in refractory period at times, possibly leading to some inappropriate atrial pacing during atrial tachycardia (at)/atrial fibrillation (af) episodes.  the ra lead remains in use.  no patient complications have been reported as a result of this event.
Event or Problem Description
It was reported that the patient experienced chest pressure and shortness of breath.It was also reported that during use of the ca rdiac resynchronization therapy pacemaker (crt-p), atrial events appeared to be falling in refractory period at times, possibly leading to some inappropriate atrial pacing during atrial tachycardia (at)/atrial fibrillation (af) episodes.The crt-p remains in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Correction: b5.Desc evt problem, d1., d2., d3., d4., g3., g4., additional codes: img (annex g) component medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Correction: h6.Patient codes (ime/annex e), additional codes: imf (annex f) health impact.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was further reported that reprogramming was done.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CONSULTA CRT-P
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud PR 1131 ; SZ 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud PR 1131 ; SZ 1131
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635269277
• MDR Report Key: 19820451
• Report Number: 2649622-2024-19581
• Device Sequence Number: 8679854
• Product Code: NVZ
• UDI-Device Identifier: 00613994713667
• UDI-Public: 00613994713667
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P010015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/28/2018
• Device Model Number: C4TR01
• Device Catalogue Number: C4TR01
• 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: 06/28/2024
• Supplement Date Received by Manufacturer: 07/24/2024; 07/24/2024; 07/25/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 07/24/2024; 07/24/2024; 08/14/2024
• Date Device Manufactured: 03/29/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 419688 LEAD, C4TR01 CRT-P, 5076-52 LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 64 KG