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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 Problem Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/05/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a routine clinic visit, the mobile programmer was unable to interrogate the implantable cardioverter defibrillator (icd) and it was then attempted to interrogate with a second mobile programmer however the same issue was experienced. It was noted that the lights on the patient connectors kept going from green to yellow and could not detect the icd and there were no error messages observed. 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 Key11928849
MDR Text Key253972336
Report Number2182208-2021-02259
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P890003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received06/16/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/29/2020
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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