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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS CAPSUREFIX NOVUS LEAD MRI SURESCAN PERMANENT PACEMAKER ELECTRODE

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MEDTRONIC SINGAPORE OPERATIONS CAPSUREFIX NOVUS LEAD MRI SURESCAN PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 5076-52
Device Problems Signal Artifact/Noise (1036); Electromagnetic Interference (1194); Over-Sensing (1438)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/14/2022
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 cardiac resynchronization therapy pacemaker (crt-p) experienced noise or interference that potentially impacted the right side functioning of the system. The device remains in use. No patient complications have been reported as a result of this event.
 
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Brand NameCAPSUREFIX NOVUS LEAD MRI SURESCAN
Type of DevicePERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
MEDTRONIC SINGAPORE OPERATIONS
49 changi south avenue 2
nasaco tech centre
singapore 48605 6
SN 486056
Manufacturer (Section G)
MEDTRONIC SINGAPORE OPERATIONS
49 changi south avenue 2
nasaco tech centre
singapore 48605 6
SN 486056
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key14194546
MDR Text Key289987297
Report Number9614453-2022-01178
Device Sequence Number1
Product Code DTB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P930039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/16/2022
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received04/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/19/2022
Device Model Number5076-52
Device Catalogue Number5076-52
Was Device Available for Evaluation? No
Date Manufacturer Received05/13/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/05/2020
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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