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

Model Number	DTMA1Q1
Medical Device Problem Code	Reset Problem (3019)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 5076-52 lead, implanted (b)(6) 2014.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) alerted for an electrical reset during interrogation.Software was successfully uploaded and the device is still in use.No patient complications have been reported as a result of this event.

• Brand Name: CLARIA MRI QUAD 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: 10606911
• Report Number: 3004209178-2020-16958
• Device Sequence Number: 1151580
• Product Code: NIK
• UDI-Device Identifier: 00643169705760
• UDI-Public: 00643169705760
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2020

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: 05/14/2018
• Device Model Number: DTMA1Q1
• Device Catalogue Number: DTMA1Q1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 09/30/2020
• 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: 439888 LEAD, 693565 LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR