MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. CLARIA MRI CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number	DTMA1D4
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
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 the remote monitor was unable to establish telemetry with the cardiac resynchronization therapy defibrillator ( crt-d).The patient rebooted the monitor and reset the reader but the issue was unresolved.The patient was referred to the clinic.The crt-d and monitor remain in use.No patient complications have been reported as a result of this event.

• Brand Name: CLARIA MRI CRT-D SURESCAN
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11724673
• Report Number: 3004209178-2021-06668
• Device Sequence Number: 3438055
• Product Code: NIK
• UDI-Device Identifier: 00643169543416
• UDI-Public: 00643169543416
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2021

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: 04/28/2018
• Device Model Number: DTMA1D4
• Device Catalogue Number: DTMA1D4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 04/26/2021
• 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: 6947M55 LEAD, 5076-52 LEAD, 383069 LEAD.
• Patient Age: 61 YR