MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL VIVA CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number	C6TR01
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Codes	Tachycardia (2095); Syncope/Fainting (4411)
Date of Event	05/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Follow up was conducted and it was further reported that the crt-p had normal battery depletion with no fluctuations noted, the patient's high heart rate was not confirmed, and the patient's most recent procedure was a bilateral breast lumpectomy.
Additional Manufacturer Narrative
B3: date is approximate.Year is confirmed valid.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 by the patient that they had concerns about the fluctuating battery life of the cardiac resynchronization therapy pa cemaker (crt-p).The patient also stated concerns regarding their heartrate.Prior to a surgery, the patient had a resting heart rate at 260 when sleeping and 292 when sitting in clinic, and now the pulse had been in the 270s and 300s.The patient stated they went unresponsive 16 times prior to this surgery and post this surgery had been perfectly fine.The patient stated they don¿t remember the surgery name, but the medical team removed the natural pacemaker of the heart, and the patient relies on the heart device 99% of the time.The crt-p remains in use.No further patient complications have been reported as a result of this event.
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: VIVA CRT-P
• Common Device Name: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 21510634
• Report Number: 9614453-2025-00881
• Device Sequence Number: 15459066
• Product Code: NKE
• UDI-Device Identifier: 00643169351905
• UDI-Public: 00643169351905
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P010015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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: 06/28/2017
• Device Model Number: C6TR01
• Device Catalogue Number: C6TR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 03/13/2025
• Date Device Manufactured: 01/13/2016
• 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: 5076-45 LEAD, 429688 LEAD, 5076-52 LEAD.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 45 YR
• Patient Sex: Female