MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

Model Number MDT-UNKNOWN

Device Problems Signal Artifact/Noise (1036); Premature Discharge of Battery (1057); Electromagnetic Interference (1194); Incorrect Measurement (1383); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Decreased Sensitivity (2534); Impedance Problem (2950); High Capture Threshold (3266)

Patient Problems Arrhythmia (1721); Tachycardia (2095)

Event Date 08/01/2009

Event Type  Injury  

Manufacturer Narrative

Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers.The baseline gender/age characteristics is male/71 years old.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.A request for additional information was made to no avail.Upon receipt of new information, a supplemental report will be submitted accordingly.Referenced article: a low critical event rate despite a high abnormal event rate in patients with cardiac implantable electric devices followed up by remote monitoring.Internal medicine.2019; 58(16):2333-2340.Doi: 10.2169/internalmedicine.1905-18.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding remote monitoring of cardiovascular implantable electronic devices (cieds) including implantable pulse generators (ipgs), implantable cardioverter defibrillators (icds), and cardiac resynchronization therapy defibrillators (crt-ds). it was reported that of about 16,560 transmissions from 1,849 patients of various manufacturers analyzed, abnormal events included: atrial tachyarrhythmias, ventricular tachyarrhythmias, inappropriate therapy, abnormal battery voltage, triggering elective replacement indicator (eri) prematurely, and one case of unexpected battery depletion.Lead impedance abnormality, non-physiologic noise, sensing and pacing failures, increased atrial and ventricular pacing thresholds, decreased atrial and ventricular sensing were also observed.The article noted that for the basis of this study, in clinic intervention was not tracked, it is not known whether intervention took place or not.The status of the products are unknown.No further patient complications have been reported as a result of this event.

• Brand Name: MEDTRONIC
• Type of Device: PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10083252
• MDR Text Key: 193419412
• Report Number: 2182208-2020-00935
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2020

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-UNKNOWN
• Device Catalogue Number: MDT-UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2020
• Initial Date FDA Received: 05/22/2020
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 71 YR