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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS CAPSUREFIX NOVUS MRI SURESCAN; PERMANENT PACEMAKER ELECTRODE
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MEDTRONIC SINGAPORE OPERATIONS CAPSUREFIX NOVUS MRI SURESCAN; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 407645
Medical Device Problem Code Over-Sensing (1438)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/30/2021
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 atrial (ra) lead exhibited oversensing.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 MRI SURESCAN
Common Device Name
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
MEDTRONIC SINGAPORE OPERATIONS
49 changi south avenue 2
nasaco tech centre
singapore 48605 6
SN  486056
MDR Report Key12311531
Report Number3008973940-2021-02887
Device Sequence Number4173514
Product Code DTB
UDI-Device Identifier00763000014636
UDI-Public00763000014636
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
P930039
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/12/2021
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 Date10/16/2019
Device Model Number407645
Device Catalogue Number407645
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/24/2021
Initial Report FDA Received Date08/12/2021
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
W1DR01 IPG, 407652 LEAD
Patient Age82 YR
Patient Weight100
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