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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. PACEART; ELECTROCARDIOGRAPH
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MEDTRONIC, INC. PACEART; ELECTROCARDIOGRAPH Back to Search Results
Model Number DL10
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Date 07/17/2014
Event Type  malfunction  
Event Description
It was reported that the client indicated that while conducting readings for the patients through the application, the same readings were received for each patient.The client requested new leads and cable for the application.The new leads and cable were sent to the client.The application remains in use.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Without a lot number or device serial number, the manufacturing date cannot be determined.(b)(4).
 
Event Description
It was reported that the client indicated that while conducting readings for the patients through the application, the same readings were received for each patient.The client requested new leads and cable for the application.The new leads and cable were sent to the client.The application remains in use.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).
 
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Brand Name
PACEART
Type of Device
ELECTROCARDIOGRAPH
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC CARDIAC RHYTHM HEART FAILURE
8200 coral sea st ne
mounds view MN 55112
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key4158489
MDR Text Key4787878
Report Number2182208-2014-02631
Device Sequence Number1
Product Code DPS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K024278
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 07/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDL10
Device Catalogue NumberDL10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/17/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
D8052 CABLE
Patient Outcome(s) Required Intervention;
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