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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 Failure to Interrogate (1332)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/08/2019
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 prior to implant, an attempt was made to interrogate the implantable pulse generator (ipg) however, a telemetry problem occurred and the ipg would not accept data.The ipg was not implanted and another ipg was used.No 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 Key8392503
Report Number3008973940-2019-00575
Device Sequence Number11134500
Product Code NVZ
UDI-Device Identifier00643169709065
UDI-Public00643169709065
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
P980035
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/05/2019
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 Health Professional
Device Expiration Date03/28/2019
Device Model NumberSESR01
Device Catalogue NumberSESR01
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/08/2019
Initial Report FDA Received Date03/05/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age88 YR
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