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

Model Number DTPB2QQ

Device Problems Failure to Capture (1081); High impedance (1291); Misconnection (1399)

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

Event Date 07/15/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the left ventricular (lv) lead was inadvertently inserted into the right ventricular lead port of the cardiac resynchronization therapy defibrillator (crt-d) and vice versa during implant.Normal impedance values were noted via the analyzer but high undefined pacing and defibrillation impedance were noted when the lead implanted in the left ventricle was connected to the crt-d.Lead capture was confirmed via the analyzer but there was no capture when plugged into the crt-d.The lead was removed from the port several times for inspection.The lead appeared to be fully inserted into the crt-d per an x-ray.The physician suspected an issue with the crt-d's right ventricular port.It was subsequently confirmed that the leads had been reversed in the crt-d header and the lead was not fully inserted into the device.The leads were connected to the correct ports.The lv lead and crt-d were implanted and 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: 12316963
• MDR Text Key: 266376567
• Report Number: 9614453-2021-03216
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00763000178178
• UDI-Public: 00763000178178
• 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: 08/12/2021

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 Expiration Date: 09/28/2022
• Device Model Number: DTPB2QQ
• Device Catalogue Number: DTPB2QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2021
• Initial Date FDA Received: 08/12/2021
• Date Device Manufactured: 04/06/2021
• 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
• Patient Age: 52 YR