MAUDE Adverse Event Report: MEDTRONIC, INC.

Model Number 5943

Device Problems Electromagnetic Interference (1194); Pacing Problem (1439)

Patient Problems Dizziness (2194); Loss of consciousness (2418)

Event Date 08/30/1972

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.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: pacemaker interference caused by an escalator journal of clinical engineering 1977;2(2):153-6.Doi: 10.1097/00004669-197704000-00013.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding an implantable pulse generator (ipg).The authors discussed a case where there was pacemaker inhibition due to electrical discharges from an escalator.The patient complained of ¿fainting spells, often with loss of consciousness when riding up an escalator.¿ monitor tracings revealed the pacemaker originated qrs disappeared even with an atrial rate.The patients own escape rhythm appeared at which time there was marked dizziness.Following, the escape rhythm was sporadically interrupted by pacemaker firing until full resumption of pacemaker activity.During the sequence of events there was a period of ventricular asystole.The status/disposition of the ipg 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.

• 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: 10563484
• MDR Text Key: 207894594
• Report Number: 2182208-2020-01985
• 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: consumer,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2020

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: 5943
• Device Catalogue Number: 5943
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 09/21/2020
• 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: 47 YR