MAUDE Adverse Event Report: MEDTRONIC, INC. COBALT XT DR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number DDPA2D4

Patient Problems Dyspnea (1816); Dizziness (2194); Palpitations (2467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/06/2023

Event Type  Injury  

Event Description

The patient is a 64 year old female who had a 3 year history of pvcs for which she was treated with a beta blocker.She had covid in december which made her symptoms worse.On (b)(6) she presented with shortness of breath and palpitations.She was found to have tri-fascicular block and exercise-induced 2:1 av block.A pet scan suggested sarcoidosis.On (b)(6) she underwent placement of a dual-chamber pacemaker and aicd.The device was tested and found to be functioning properly.Following discharge, she began to experience palpitations.She was placed on telemetry where it was found occasional p-waves were not tracked.The device was checked by ep and no malfunction was found.She followed up with her provider on (b)(6) who put on a ziopatch monitor for two weeks.On (b)(6) she was re-admitted with complaints of palpitations and lightheadedness.On the monitor, her lowest heart rate was 34 bpm.Because of pacemaker malfunction, on (b)(6) the pulse generator was changed and the rv pacing lead was removed and replaced.The original device and lead were sent to the manufacturer for analysis.The patient was discharged home on (b)(6).Nothing in the enclosed report constitutes an admission of any kind that the hospital or any of its employees or affiliated personnel caused or contributed in any way to the occurrence or any harm set forth in the report or that the hospital or any of its employees or affiliated personnel caused or contributed to any alleged medical device malfunction.Ref report: mw5119797.

• Brand Name: COBALT XT DR MRI SURESCAN
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 17372557
• MDR Text Key: 319620381
• Report Number: MW5119796
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/18/2023

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
• Device Operator: Health Professional
• Device Model Number: DDPA2D4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White