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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

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MEDTRONIC, INC. MEDTRONIC CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number MDT-CRT-P
Device Problems Pacing Problem (1439); Unable to Obtain Readings (1516)
Patient Problems Syncope (1610); Atrial Fibrillation (1729); Tachycardia (2095)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient experienced sustained atrial arrhythmia and was not paced for twenty minutes. The patient states that the device did not record this event or other events when they "pass out, suffer atrial fibrillation and tachycardia". The device remains in use. No further patient complications have been reported as a result of this event.
 
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Brand NameMEDTRONIC CRT-P
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
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 Key9488868
MDR Text Key174357401
Report Number2182208-2019-02314
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 12/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMDT-CRT-P
Device Catalogue NumberMDT-CRT-P
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/23/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/18/2019 Patient Sequence Number: 1
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