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

Model Number	DTMB1Q1
Medical Device Problem Code	Reset Problem (3019)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 429888 lead, implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during use of the cardiac resynchronization therapy defibrillator (crt-d), a power on reset (por) occurred in initial interrogation.The reset was cleared.The crt-d remains in use.No patient complications have been reported as a result of this event.

• Brand Name: AMPLIA 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: 10643403
• Report Number: 3004209178-2020-17438
• Device Sequence Number: 16824268
• Product Code: NIK
• UDI-Device Identifier: 00643169705784
• UDI-Public: 00643169705784
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2020

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: 06/14/2018
• Device Model Number: DTMB1Q1
• Device Catalogue Number: DTMB1Q1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/07/2020
• 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: 694765 LEAD, 407652 LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 129