MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL COBALT¿ XT HF QUAD CRT-D MRI SURESCAN¿; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTPA2Q1

Device Problems Unable to Obtain Readings (1516); Missing Test Results (3267)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2021

Event Type  Injury  

Manufacturer Narrative

Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated an issue with missing/invalid diagnostic data.Analysis of the device memory indicated the battery measurement was not available.Concomitant medical products: product id: 6935 lead, implanted: (b)(6) 2018; product id: 4298 lead, implanted: (b)(6) 2021.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the cardiac resynchronization therapy defibrillator (crt-d) was stuck in a non-wireless telemetry session.The device was interrogated, and the persistent session active flag was cleared using a non-bluetooth telemetry session.The device remains in use.No patient complications have been reported as a result of this event.

• Brand Name: COBALT¿ XT HF QUAD CRT-D MRI SURESCAN¿
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 15125392
• MDR Text Key: 296840703
• Report Number: 9614453-2022-02254
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/14/2022
• Device Model Number: DTPA2Q1
• Device Catalogue Number: DTPA2Q1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2182208-042122-002-C
• Patient Sequence Number: 1
• Treatment: 5076
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male