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U.S. Department of Health and Human Services

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

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MEDTRONIC, INC. PATIENT CONNECTOR DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number 24967
Device Problems Computer Software Problem (1112); Display or Visual Feedback Problem (1184); Device Difficult to Program or Calibrate (1496); Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/16/2021
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that prior to procedure and after programming all settings in a cardiac resynchronization therapy pacemaker (crt-p), the mobile programmer application crashed and displayed a diagnostic message. It was also reported that there was a loss of communication between the patient connector and the tablet. The patient connector and mobile programmer application remains in use. There was no patient involvement.

 
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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 Key12216313
MDR Text Key263107293
Report Number2182208-2021-02928
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberP890003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/18/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/23/2021
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 Received07/23/2021
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

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