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

Model Number DDMB1D4

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erythema (1840); Unspecified Infection (1930); Burning Sensation (2146); Implant Pain (4561); Swelling/ Edema (4577)

Event Date 03/18/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 5076-52 lead implanted: (b)(6) 2006; tyrx implanted: (b)(6) 2021.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient came into the hospital for pain and burring at the implantable cardioverter defibrillator (icd) site saying it was painful when they moved their arm.Several months alter the patient called in saying that there the device was pinching them, and it feels as if the device might come through their skin.The next day when the patient went into the hospital to have their device checked there was neuropathic pain over top of the device and a severe sharp stabbing pain beneath the device.It was noted that the device was somewhat raised and not flush with the pectorals plane as well as having scabbing over the device site.A pocket revision occurred, and an antibacterial absorbable envelope was implanted.Five weeks after the procedure the patient called in saying there was a ¿red spot with a crusty center on the device site¿ an infection was suspected, and antibiotics were administered.Subsequently the swelling and redness improved.The device remains in use and the antibacterial absorbable envelope remains in the patient.The patient is a participant in a clinical study.No further patient complications have been reported as a result of this event.

• Brand Name: EVERA MRI XT DR 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: 12614647
• MDR Text Key: 275876343
• Report Number: 9614453-2021-03947
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00763000059491
• UDI-Public: 00763000059491
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980016
• 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: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/14/2022
• Device Model Number: DDMB1D4
• Device Catalogue Number: DDMB1D4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2021
• Date Device Manufactured: 10/20/2020
• 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: 6935M62 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR