• 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 No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/17/2021
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 of the mobile programmer lost charge after device interrogation in an implant procedure. A diagnostic message instructing the user to connect the patient connector to mains to re-establish telemetry was displayed. The patient connector was charged but unable to re-establish telemetry. It was noted that the loss of telemetry occurred during lead analysis and the session had to be ended to re-interrogate. No patient complications have been reported as a result of this 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 Key12180594
MDR Text Key261923096
Report Number2182208-2021-02854
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberP890003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/04/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/16/2021
Is This An Adverse Event Report? No
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 Received08/03/2021
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: 07/16/2021 Patient Sequence Number: 1
Treatment
24970A SMARTSYNC PROGRAMMER
-
-