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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IPG MFG SWITZERLAND ADVISA SR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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IPG MFG SWITZERLAND ADVISA SR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number A3SR01
Medical Device Problem Code Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/16/2018
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
The patient reported that they were unsure if their implantable pulse generator (ipg) was working properly or not.The device remains in use.No patient complications have been reported as a result of this event.
 
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Brand Name
ADVISA SR MRI SURESCAN
Common Device Name
PULSE GENERATOR, PERMANENT, IMPLANTABLE
Manufacturer (Section D)
IPG MFG SWITZERLAND
route du molliau 31
tolochenaz 1131
CH  1131
MDR Report Key7503062
Report Number3002807576-2018-00147
Device Sequence Number1550934
Product Code NVZ
UDI-Device Identifier00763000059620
UDI-Public00763000059620
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P980035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/10/2018
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 Date04/28/2019
Device Model NumberA3SR01
Device Catalogue NumberA3SR01
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/16/2018
Initial Report FDA Received Date05/10/2018
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
507652 LEAD
Patient Age81 YR
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