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

Model Number	W3DR01
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/05/2019
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 implantable pulse generator (ipg) had an electrical reset.The ipg remains in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated a software error.Analysis of the device memory indicated that the atrial and ventricular rate histogram data was missing/invalid.Analysis of the device memory indicated the battery measurement was not available.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was further reported that reprogramming was scheduled.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated a power on reset occurred.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AZURE S DR MRI SURESCAN
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• MDR Report Key: 8844922
• Report Number: 9614453-2019-02585
• Device Sequence Number: 2730654
• Product Code: NVZ
• UDI-Device Identifier: 00643169871922
• UDI-Public: 00643169871922
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/03/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/14/2019
• Device Model Number: W3DR01
• Device Catalogue Number: W3DR01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 07/31/2019; 08/27/2019; 10/03/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 08/07/2019; 09/25/2019; 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 407652 LEAD, 407658 LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR