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

Model Number DTMB1QQ

Device Problems Failure to Deliver Shock/Stimulation (1133); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Device Sensing Problem (2917)

Patient Problems Cardiac Arrest (1762); Nausea (1970); Pain (1994); Tachycardia (2095); Vomiting (2144)

Event Date 03/03/2020

Event Type  Death  

Manufacturer Narrative

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 by the patient¿s spouse that the patient is deceased.The patient¿s spouse alleges that the patient¿s death is due to a defective cardiac resynchronization therapy defibrillator (crt-d) that ¿never displayed error messages such as recommend replacement, and full battery depletion.Yet, the facility nurse confirmed that the device had extremely low battery life.A few days before the patient expired, the patient¿s family member inquired with a clinical representative about the battery life of the crt-d at the time, because the device had gone off so many times needlessly.¿ the patient¿s spouse alleges that the ¿clinical representative shared with a family member that the battery was ridiculously low.¿ the patient¿s spouse noted that prior to hospitalization a remote monitor transmission was reviewed by the physician and no issues were identified.The patient¿s spouse stated that during hospitalization ¿the patient was getting shocked (therapy) unnecessarily making the heart weaker and weaker with every shock.The night the patient needed the device most the device did not perform.The shock therapy didn¿t happen.The device shocked so many times when it shouldn¿t have, and the device failed so many times when it should have triggered and had a suspicion it was not working right; it wasn't tracking right.¿ the patient¿s spouse noted that two weeks prior to the patient¿s death ¿the defibrillator wasn¿t performing as it should.¿ the patient¿s spouse stated that the crt-d was interrogated by the manufacturers field representative, and no issues were found with the device.The patient is reported to have ¿suffered serious side effects, extreme pain and suffering for approximately three weeks, perhaps even longer before demise.¿ the patient¿s spouse further noted that the patient was administered an antiarrhythmic medication known ¿to increase the risk of death as the device did not function properly.¿.

Manufacturer Narrative

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 further reported that the cause of death was not provided.However, the circumstances of death/medical history was provided as: end-stage renal disease (esrd), ischemic cardiomyopathy, chronic systolic heart failure, coronary artery disease, and ventricular tachycardia (vt) storm.

Manufacturer Narrative

A voluntary medwatch form 3500/3500b was received.Since f10 is not contained on that form, select fields in section f have been populated by the manufacturer.F1 user facility f2 uf/importer report number: unknown f3 user facility name/address: unknown f4 contact person: unknown f5 phone number: unknown f6 date user facility became aware of event: unknown f7 type of report: supplemental f8 date of this report: 2023-10-20 f9 approximate age of device: unknown f10 event problem codes: unknown f11 report sent to fda: unknown f12 location where event occurred: unknown f13 report sent to manufacturer: yes f14 manufacturer name and address mfr.Name: medtronic, plc addl: 8200 coral sea street ne city: mounds view state: mn zip: 55112 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 further reported that the patient had runs of non-sustained ventricular tachycardia (nsvt) during the vt storm that were appr opriately not treated.It was further reported that the patient had coded, and received compressions for about a minute until there was a return of spontaneous circulation (rosc).The patient had experience nausea, vomiting and feeling hot, and they received intr avenous (iv) medication.The device settings were adjusted to change the parameters of vt detection to a lower rate so that the vt episodes would be treated sooner.The lower pacing rate was increased to minimize post-premature ventricular contractions (pvc) pauses.Further programming was done to adjust the anti-tachycardia pacing (atp) parameters because the previous settings were not effectively treating the patient.All the reprogramming was done to optimize the treatment provided to the patient and no device malfunctions were observed.The cause of death was provided as cardiac arrest due to ventricular tachycardia (vt).

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: AMPLIA MRI QUAD 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: 16585741
• MDR Text Key: 311711442
• Report Number: 3004209178-2023-03823
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169929647
• UDI-Public: 00643169929647
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/18/2024

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/14/2019
• Device Model Number: DTMB1QQ
• Device Catalogue Number: DTMB1QQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 05/17/2023; 09/26/2023; 03/25/2024
• Supplement Dates FDA Received: 05/25/2023; 10/20/2023; 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/15/2017
• 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: 459888, LEAD, 5076-52, LEAD, 6935M62, LEAD.
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male