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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Syncope (1610); Cellulitis (1768); Edema (1820); Fever (1858); Incontinence (1928); Unspecified Infection (1930)

Event Date 02/05/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 4296-88 lead, implanted: (b)(6) 2012; 5076-52 lead, implanted: (b)(6) 2012.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented to the emergency room with a syncopal event, incontinence, edema and redness bilaterally on lower extremities with suspected cellulitis.The left pectoral cardiac resynchronization therapy defibrillator (crt-d) site was red and hot to the touch and the patient was febrile.Suspected pocket infection was noted.Pocket evacuation and a drain was inserted.Cultures were sent and the patient received antibiotic treatment.The crt-d system was later explanted and replaced.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: 8400834
• MDR Text Key: 138139720
• Report Number: 3004209178-2019-04756
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169837676
• UDI-Public: 00643169837676
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2020
• Device Model Number: DTMA1D1
• Device Catalogue Number: DTMA1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2019
• Date Device Manufactured: 10/05/2018
• 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: 6947-65 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 158