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

Model Number MDT-ICD

Device Problems Signal Artifact/Noise (1036); Electromagnetic Interference (1194); Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature.All information provided is included in this report.Patient information is limited due to confidentiality concerns.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.Of note, multiple patients and multiple manufacturers were noted in the article; however, a one to one correlation could not be made without unique manufacturer/device serial numbers.The baseline gender/age characteristic is female/58 years old.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.The pma number for this report is listed as p900061 referenced article: electromagnetic interference with protocolized electrosurgery dispersive electrode positioning in patients with implantable cardioverter defibrillators anesthesiology.2019; 130(4):530-540.10.1097/aln.0000000000002571.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding implantable cardioverter defibrillators (icds).The authors discussed cases of electromagnetic interference (emi) in the operative setting.The article contained information showing there was emi which resulted in inappropriate anti-tachycardia therapy due to non-life threatening arrhythmia or over-sensing, and inappropriate anti-tachycardia pacing.A case of device related t wave over-sensing was identified.Additionally, during the pre-operative period, problems of a battery at elective replacement indication, and inadequate pacing safety margins on the ventricular and atrial channels were discovered.Of note, ¿post-operative interrogation demonstrated that all icds withstood intraoperative emi without malfunction or occurrence of unanticipated programming changes.¿ the status/disposition of the icds outside of what was described for emi is not known.Further follow up did not yet yield any additional information.No further patient complications have been reported as a result of this event.

• Brand Name: MEDTRONIC ICD
• 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: 9512930
• MDR Text Key: 174357518
• Report Number: 2182208-2019-02354
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2019

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-ICD
• Device Catalogue Number: MDT-ICD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/23/2019
• 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): Life Threatening
• Patient Age: 58 YR
• Patient Weight: 95