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

Model Number DTPB2Q1

Device Problems High impedance (1291); Mechanical Problem (1384); Misconnection (1399); Low impedance (2285); Impedance Problem (2950)

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

Event Date 03/03/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant products: 439878 lead implanted: (b)(6) 2021.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on the day of the cardiac resynchronization therapy defibrillator (crt-d) implant procedure, the chronic right ventricular (rv) lead pacing impedance dropped to below the lower impedance alert threshold.Approximately twelve days later, the rv lead superior vena cava (svc) coil impedance measurements were high and low, triggering an audible alert tone.The patient was seen and pocket manipulations were performed.There were a few high svc coil impedance values observed and then the values were consistently within range.Further testing was performed and variable svc coil impedance measurements were seen.A suspected svc coil fracture or a setscrew issue with the cardiac resynchronization therapy defibrillator (crt-d) svc port was noted.The svc coil was scheduled to be turned off and the rv lead and crt-d remain in use.No patient complications have been reported as a result of this event.

• Brand Name: COBALT 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: 11640811
• MDR Text Key: 244623103
• Report Number: 9614453-2021-01453
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00763000178185
• UDI-Public: 00763000178185
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/14/2021
• Device Model Number: DTPB2Q1
• Device Catalogue Number: DTPB2Q1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 04/09/2021
• Date Device Manufactured: 11/26/2019
• 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: 5076-45 LEAD, 694758 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR