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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS CAPSURE SENSE LEAD MRI SURESCAN; PERMANENT PACEMAKER ELECTRODE
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MEDTRONIC SINGAPORE OPERATIONS CAPSURE SENSE LEAD MRI SURESCAN; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 407452
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 09/10/2021
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 the patient experienced an infection.The implantable pulse generator (ipg) system was removed and replaced with a leadless implantable pulse generator (ipg).The ipg system was sent for analysis of bacteria.No further patient complications have been reported as a result of this event.
 
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Brand Name
CAPSURE SENSE LEAD 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 Key12542600
Report Number3008973940-2021-03532
Device Sequence Number11768184
Product Code DTB
UDI-Device Identifier00643169448940
UDI-Public00643169448940
Combination Product (Y/N)Y
Initial Reporter StateAL
Initial Reporter CountryUS
PMA/510(K) Number
P830061
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/28/2021
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? No
Operator of Device Lay User/Patient
Device Expiration Date11/07/2019
Device Model Number407452
Device Catalogue Number407452
Was Device Available for Evaluation? No
Type of Report(Section G)Fifteen-Day
Initial Date Received by Manufacturer 09/10/2021
Initial Report FDA Received Date09/28/2021
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
5076-45 LEAD,W3DR01 IPG
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age86 YR
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