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

Model Number DTMA1D4

Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477); Diminished Pulse Pressure (2606)

Event Date 06/21/2018

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the implant procedure, the patient experienced worsening hypotension and oxygen saturation.The patient was then intubated and converted to general anesthesia.Ultimately the cardiac resynchronization therapy defibrillator (crt-d) system was implanted and the patient was transferred to the critical care unit.Shortly after transfer the patient became pulseless and was resuscitated with cardiopulmonary resuscitation, epinephrine, bicarbonate, calcium, norepinephrine, and cardioversion from ventricular fibrillation (vf) to atrial fibrillation (af).Ultimately the patient developed a sinus rhythm but they remained pulseless.An echocardiogram was performed and it was negative for a pericardial effusion.The decision was made to withdraw support and the patient died.A cause of death of acidemia with hypotension and electrolyte imbalance underlying causes of dilated cardiomyopathy with an ejection fraction of ten percent and chronic kidney disease with acute injury was provided.The patient's physician also noted that they felt the patient was so compromised that they were unable to tolerate the anesthesia required for any procedure.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.This device was reported as included in the field action noted but returned product investigation found the device did not perform as described in the field action.The device is no longer included as part of the field action.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7710293
• MDR Text Key: 114705626
• Report Number: 3004209178-2018-16370
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169720657
• UDI-Public: 00643169720657
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/04/2018

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2019
• Device Model Number: DTMA1D4
• Device Catalogue Number: DTMA1D4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 07/23/2018
• Supplement Dates Manufacturer Received: 07/31/2018; 08/08/2018; 08/08/2018
• Supplement Dates FDA Received: 08/01/2018; 10/04/2018; 10/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0962-2017
• Patient Sequence Number: 1
• Treatment: 6935M62 LEAD, 5076-52 LEAD
• Patient Outcome(s): Death
• Patient Age: 62 YR