MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL ADVISA MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	A2DR01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary:the device was returned and analyzed.The returned device identified a failure condition that disappeared during analysis.Analysis of the hybrid revealed that there was a save to disk data to review as the device had showed that the device had depleted at a faster rate than expected.Both loaded and unloaded pacing current drain levels were high for this device.There was evidence of a high current drain condition on the hybrid.Additional analysis of the hybrid at product analysis laboratory, tempe revealed the device had nominal current drain when received in pal on the powered carrier.The reported failure had cleared during transit.Attempts to reintroduce the elevated current drain were unsuccessful.Current drain remained nominal with the device at 37ºc and test patterns loaded into memory.No ctas or other anomalies were noted on the sawn edges of the scsp.No anomalies were noted on the flip-chip ic solder bumps during x-ray inspection.No hybrid anomalies were identified.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
The implantable pulse generator (ipg) was returned to the manufacturer, analyzed, and tested out of specification.No patient complications have been reported as a result of this event.

• Brand Name: ADVISA MRI SURESCAN
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 20462045
• Report Number: 9614453-2024-04029
• Device Sequence Number: 8855816
• Product Code: NVZ
• UDI-Device Identifier: 00763000059613
• UDI-Public: 00763000059613
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2024

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 Date: 04/14/2019
• Device Model Number: A2DR01
• Device Catalogue Number: A2DR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 407658 LEAD, 507658 LEAD.
• Patient Sex: Female