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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)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/26/2021
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that when using the programmers patient connector and during attempts to perform ventricular sensing test , a incomplete test diagnostic message kept displaying. "not enough sensed events to complete sensing measurements. Select start measurement to measure again. If pacing adjust the lower rate to get normal sinus rhythm. " it was noted however that every r wave was sensed. Troubleshooting is ongoing. The patient connector remains in use. No patient complications have been reported as a result of this event.

 
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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 Key12033213
MDR Text Key257190231
Report Number2182208-2021-02510
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP890003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/27/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/21/2021
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2021
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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