MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL COBALT¿ XT DR MRI SURESCAN¿; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number DDPA2D4

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 12/03/2021

Event Type  Injury  

Event Description

It was reported that two months post implant, elevated thresholds were noted on the right atrial (ra) and right ventricular (rv) leads.The patient was brought in and it was determined the ra lead had dislodged and the rv lead was noted to have a loss of slack.The ra lead was explanted and replaced.The rv lead received additional slack and was repositioned.Three days later, it was noted that the fascial structure was very loose.When the patient was lying down there was no issue noted but upon standing and moving in the upright position the implantable cardioverter defibrillator (icd) migrated resulting in the dislodgement of the newly implanted right atrial (ra) lead and rv lead.The physician opted to explant and replace the ra lead and device.The rv lead was repositioned and remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Concomitant medical products: product id: 6935m62 lead, implanted: (b)(6) 2021.If information is provided in the future, a supplemental report will be issued.

• Brand Name: COBALT¿ XT DR MRI SURESCAN¿
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 13120151
• MDR Text Key: 283083379
• Report Number: 9614453-2021-04780
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P980016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/14/2022
• Device Model Number: DDPA2D4
• Device Catalogue Number: DDPA2D4
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2021
• Date Device Manufactured: 06/24/2021
• 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
• Treatment: 5076-58 LEAD.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 110 KG