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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
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MEDTRONIC; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number MDT-CRT-P
Device Problem Failure to Interrogate (1332)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/30/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the company representative noted that the some of the models of implantable pulse generator (ipg)'s and the cardiac resynchronization therapy pacemaker (crt-p)'s lose telemetry during atrio-ventricular node ablations.No patient complications have been reported as a result of this event.
 
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Type of Device
PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
Manufacturer (Section D)
MEDTRONIC
8200 coral sea st. n. e.
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC
8200 coral sea st. n. e.
mounds view MN 55112
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7417906
MDR Text Key105274660
Report Number2182208-2018-00568
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMDT-CRT-P
Device Catalogue NumberMDT-CRT-P
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/30/2018
Initial Date FDA Received04/10/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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