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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS CAPSUREFIX NOVUS; ELECTRODE, PACEMAKER, PERMANENT
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MEDTRONIC SINGAPORE OPERATIONS CAPSUREFIX NOVUS; ELECTRODE, PACEMAKER, PERMANENT Back to Search Results
Model Number 407658
Medical Device Problem Codes Electrical /Electronic Property Problem (1198); High impedance (1291)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/12/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the right ventricular (rv) lead had a polarity switch and high bipolar lead impedance measurements.The lead remains in use.No patient complications have been reported as a result of this event.
 
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Brand Name
CAPSUREFIX NOVUS
Common Device Name
ELECTRODE, PACEMAKER, PERMANENT
Manufacturer (Section D)
MEDTRONIC SINGAPORE OPERATIONS
49 changi south avenue 2
nasaco tech centre
singapore 48605 6
SG  486056
MDR Report Key8043557
Report Number3008973940-2018-02221
Device Sequence Number19243321
Product Code DTB
UDI-Device Identifier00763000014650
UDI-Public00763000014650
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P930039
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/06/2018
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
Operator of Device Lay User/Patient
Device Expiration Date10/05/2019
Device Model Number407658
Device Catalogue Number407658
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/12/2018
Initial Report FDA Received Date11/06/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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