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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 Code Signal Artifact/Noise (1036)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/18/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that there was noise on the right ventricular (rv) lead in unipolar configuration.The device was interrogated and the lead was reprogrammed to bipolar sensing.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 Key8337016
Report Number3008973940-2019-00277
Device Sequence Number16549339
Product Code DTB
UDI-Device Identifier00763000014650
UDI-Public00763000014650
Combination Product (Y/N)N
Initial Reporter StateOR
Initial Reporter CountryUS
PMA/510(K) Number
P930039
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date11/06/2019
Device Model Number407658
Device Catalogue Number407658
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/18/2019
Initial Report FDA Received Date02/13/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
W3DR01 IPG, 407652 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age71 YR
Patient Weight109
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