• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. PATIENT CONNECTOR DETECTOR AND ALARM, ARRHYTHMIA

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC, INC. PATIENT CONNECTOR DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number 24967
Device Problems Display or Visual Feedback Problem (1184); Communication or Transmission Problem (2896)
Patient Problem Asystole (4442)
Event Date 07/12/2021
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that the patient connector and the tablet operating system continuously lost connection during the testing of the device in the patient pocket. It was noted that it was a new right ventricular (rv) lead procedure in a pacing dependent patient and upon connection of the new lead to the new can there was a loss of capture and an asystole that lasted for numerous seconds. Troubleshooting steps were taken to restore the connection but the issue persisted. It was noted that error messages were displayed that indicated that the test was not confirmed and the user was unable to complete the tests in a timely manner. It was noted that the loss of connection occurred a large number of times and testing of the lead only occurred outside of the operating theatre and the user was able to assure lead stability. The programmer remains in use. No further patient complications were reported as a result of the event.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePATIENT CONNECTOR
Type of DeviceDETECTOR AND ALARM, ARRHYTHMIA
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 Key12305946
MDR Text Key265967890
Report Number2182208-2021-03141
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberP890003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 08/11/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/11/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number24967
Device Catalogue Number24967
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 08/11/2021 Patient Sequence Number: 1
Treatment
24967 PATIENT CONNECTOR, 5076-58 LEAD
-
-