MAUDE Adverse Event Report: MEDTRONIC, INC. ENRHYTHM; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number MDT-IPG

Device Problems Premature Discharge of Battery (1057); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Atrial Fibrillation (1729)

Event Date 01/01/2014

Event Type  Death  

Event Description

A journal article was reviewed which contained information regarding implantable pulse generators (ipgs).Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device serial numbers.Patient deaths were referenced in the article, with no specific device serial number correlation or cause of death indicated.Other complications/failure modes were listed as: premature battery depletion, infection, permanent atrial fibrillation (af), and pulmonary edema.The status of the device is unknown.The cause of death has been requested and follow up did not yet yield any additional information.

Manufacturer Narrative

This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.If additional relevant information is received, a supplemental report will be submitted.Patient information is limited due to confidentiality concerns.The date of death is purely an estimate, as there is no direct indication of medtronic-device related deaths.The gender of the baseline characteristics is male and the baseline age is (b)(6).Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.The pma number for this report listed is part of a combination of pmas considered the "1-card" and consists of p820003, p850051, p890003, p930022, p970012 and p980035.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.Referenced article: atrial antitachycardia pacing and managed ventricular pacing in bradycardia patients with paroxysmal or persistent atrial tachyarrhythmias: the minerva randomized multicentre international trial.European heart journal.2014;35(35):2352-2362.(b)(4).

Manufacturer Narrative

This medical device report is being resubmitted to the emdr system due to a connection error within the emdr system.The event was previously reported to the emdr portal and an acknowledgement 3 received, but the connection error prevented the emdr system from documenting the report.The report number in this report is the same number as the impacted report that has the connection issue.This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.If additional relevant information is received, a supplemental report will be submitted.Patient information is limited due to confidentiality concerns.The pma number for this report listed is part of a combination of pmas considered the "1-card" and consists of p820003, p850051, p890003, p930022, p970012 and p980035.Referenced article: atrial antitachycardia pacing and managed ventricular pacing in bradycardia patients with paroxysmal or persistent atrial tachyarrhythmias: the minerva randomized multicentre international trial.European heart journal.2014;35(35):2352-2362.Additional information was received which stated the cause of death for the patients referenced in the article.Information was also received which indicated that all applicable events have been reported to the appropriate authorities.Multiple causes of death included: sudden cardiac death, cancer, traffic accident, septic shock, kidney failure, pneumonia, brain bleeding, stroke, sepsis, lung infection, aortic aneurism, and respiratory arrest.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed which contained information regarding implantable pulse generators (ipgs).Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device serial numbers.Patient deaths were referenced in the article, with no specific device serial number correlation or cause of death indicated.Other complications/failure modes were listed as: premature battery depletion, infection, permanent atrial fibrillation (af), and pulmonary edema.The status of the device is unknown.The cause of death has been requested and received.

• Brand Name: ENRHYTHM
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4358424
• MDR Text Key: 19608256
• Report Number: 2182208-2014-03804
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P850051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2019

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 Model Number: MDT-IPG
• Device Catalogue Number: MDT-IPG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2014
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: 01/20/2015
• Supplement Dates FDA Received: 06/14/2019
• 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
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 00074 YR