MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. COMPIA MRI CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTMC1D1

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problems Arrhythmia (1721); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 09/11/2023

Event Type  Death  

Event Description

It was reported that an internal review of data transmitted from the device indicated that multiple short circuit protection episodes were triggered.During three episodes of ventricular fibrillation (vf), the device provided less than programmed high voltage energy.For two of the episodes, the arrhythmia appeared to have self-terminated.The third episode was in progress at the time of data transmission however it was later identified that the patient is deceased and died on the date of transmission.

Manufacturer Narrative

Continuation of d10: 419678 lead implanted (b)(6) 2009.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.

Manufacturer Narrative

Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated that the ventricular tachyarrhythmia therapy energy was low.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.

Event Description

It was reported that an internal review of data transmitted from the device indicated that multiple short circuit protection episodes were triggered.During three episodes of ventricular fibrillation (vf), the cardiac resynchronization therapy defibrillator (crt-d) system provided less than programmed high voltage energy.For two of the episodes, the arrhythmia appeared to have self-terminated.The third episode was in progress at the time of data transmission however it was later identified that the patient is deceased and died on the date of transmission.It was further reported that the patient's cause of death was arrhythmia due to dysautonomia due to heart failure.

• Brand Name: COMPIA MRI CRT-D SURESCAN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 17959556
• MDR Text Key: 325972927
• Report Number: 3004209178-2023-17876
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169837706
• UDI-Public: 00643169837706
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/14/2021
• Device Model Number: DTMC1D1
• Device Catalogue Number: DTMC1D1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2020
• 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: 4244 LEAD, 694765 LEAD
• Patient Outcome(s): Death
• Patient Age: 59 YR
• Patient Sex: Female