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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS SENSIA SR; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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MEDTRONIC SINGAPORE OPERATIONS SENSIA SR; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number SESR01
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 01/04/2019
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 the patient experienced infection.The implantable pulse generator (ipg) system was explanted and replaced with a leadless ipg.No further patient complications have been reported as a result of this event.
 
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Brand Name
SENSIA SR
Common Device Name
PULSE GENERATOR, PERMANENT, IMPLANTABLE
Manufacturer (Section D)
MEDTRONIC SINGAPORE OPERATIONS
49 changi south avenue 2
nasaco tech centre
singapore 48605 6
SG  486056
MDR Report Key8232168
Report Number3008973940-2019-00052
Device Sequence Number16557343
Product Code NVZ
UDI-Device Identifier00643169709065
UDI-Public00643169709065
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
P980035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/09/2019
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? No
Operator of Device Lay User/Patient
Device Expiration Date04/28/2019
Device Model NumberSESR01
Device Catalogue NumberSESR01
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/04/2019
Initial Report FDA Received Date01/09/2019
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
5076-58 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age60 YR
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