MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. EVERA XT DR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	DDBB1D4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	11/14/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had general neck swelling, difficulty breathing, and possible hypersensitivity after their absorbable antibacterial envelope (aae) was implanted, intubation was necessary.The aae was explanted and replaced with a new aae.Approximately fifteen minutes after the patient's pocket was closed they had general throat swelling and some difficulty breathing.Five days later, after evaluation, the second aae was explanted.It was also reported that the patient developed a hematoma after their implantable cardioverter defibrillator (icd) was implanted.Four days after the icd was implanted, the pocket was reopened and the hematoma was evacuated.No further patient complications have been reported as a result of this event.

• Brand Name: EVERA XT DR
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 7254391
• Report Number: 3004209178-2018-02514
• Device Sequence Number: 957229
• Product Code: LWS
• UDI-Device Identifier: 00643169929128
• UDI-Public: 00643169929128
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/28/2019
• Device Model Number: DDBB1D4
• Device Catalogue Number: DDBB1D4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 86