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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 Inappropriate/Inadequate Shock/Stimulation (1574); Unauthorized Access to Computer System (3025)
Patient Problem Shock from Patient Lead(s) (3162)
Event Date 07/30/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient reported that the cardiac resynchronization therapy pacemaker (crt-p) was receiving rogue transmissions; was providing random defibrillations, and had bad information. The patient requested that their device be secured as soon as possible. The device remains in use. No 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 Key8915615
MDR Text Key155060623
Report Number2182208-2019-01536
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
Reporter Occupation
Type of Report Initial
Report Date 08/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/21/2019
Is this an Adverse Event Report? No
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
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2019
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

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