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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.The device was returned and screening analysis was performed, but no issue was identified requiring full analysis.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Concomitant medical products: 5076-52 lead, implanted: (b)(6) 2008; 694765 lead, implanted: (b)(6) 2008.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) system was removed due to vegetation noted on the atrial lead body in the patient's right atrium.Pre-extraction blood cultures were negative for bacteria growth.No further 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: 9758514
• Report Number: 3004209178-2020-04134
• Device Sequence Number: 16298282
• Product Code: NIK
• UDI-Device Identifier: 00643169929630
• UDI-Public: 00643169929630
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/14/2019
• Device Model Number: DTMB1Q1
• Device Catalogue Number: DTMB1Q1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 98