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

Model Number DTMA1D1

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 5076-58 lead, implanted: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient's device "malfunctioned".As the device was delivering repeated shocks, the patient was not able to stabilize their body and fell and broke their ankle.The device remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: CLARIA MRI CRT-D
• Type of Device: 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8599912
• MDR Text Key: 144709934
• Report Number: 3004209178-2019-09370
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169929531
• UDI-Public: 00643169929531
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2019
• Device Model Number: DTMA1D1
• Device Catalogue Number: DTMA1D1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/18/2019
• Date Device Manufactured: 08/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 694765 LEAD, 4473 LEAD
• Patient Age: 56 YR