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

Model Number	DTMB1Q1
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional concomitant medical products: 693565 lead, implanted: (b)(6) 2017; 459888 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 the cardiac resynchronization therapy defibrillator (crt-d) exhibited premature battery depletion.It was also noted the right ventricular (rv) lead and left ventricular (lv) lead had high threshold.Reprogramming of the rv and lv lead was attempted but unsuccessful.The device and leads remain in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was further reported that the crt-d, ra lead, and lv lead were explanted and replaced.
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 cardiac resynchronization therapy defibrillator (crt-d) exhibited premature battery depletion.It was also noted the right atrial (ra) lead and left ventricular (lv) lead had high threshold.Reprogramming of the ra and lv lead was attempted but unsuccessful.The device and leads remain in use.No patient complications have been reported as a result of this event.

• Brand Name: AMPLIA MRI QUAD CRT-D
• 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: 8333630
• Report Number: 3004209178-2019-03008
• Device Sequence Number: 16159318
• Product Code: NIK
• UDI-Device Identifier: 00643169929630
• UDI-Public: 00643169929630
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2019

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: 02/14/2019
• Device Model Number: DTMB1Q1
• Device Catalogue Number: DTMB1Q1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 02/12/2019; 05/14/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 02/12/2019; 05/16/2019
• 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: 58 YR