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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS CAPSURE SENSE; ELECTRODE, PACEMAKER, PERMANENT
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MEDTRONIC SINGAPORE OPERATIONS CAPSURE SENSE; ELECTRODE, PACEMAKER, PERMANENT Back to Search Results
Model Number 457445
Medical Device Problem Code Under-Sensing (1661)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/10/2018
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 atrial (ra) lead was observed with functional undersensing with atrial events falling into the blanking at times.The lead remains in use.No patient complications have been reported as a result of this event.
 
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Brand Name
CAPSURE SENSE
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 Key7664604
Report Number3008973940-2018-01485
Device Sequence Number1759168
Product Code DTB
UDI-Device Identifier00643169410954
UDI-Public00643169410954
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
P830061
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 07/05/2018
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 Date11/06/2019
Device Model Number457445
Device Catalogue Number457445
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/10/2018
Initial Report FDA Received Date07/05/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age86 YR
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