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

Model Number	DVBC3D1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	01/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical product: 7002 lead implanted: (b)(6) 2008.
Event or Problem Description
It was reported the patient presented with a small amount of bleeding at the insertion site and a small wound dehiscence was observed.It was further reported that there were no signs of infection.A liquid tissue adhesive was applied and the implantable cardioverter defibrillator (icd) remains in use.No further patient complications have been reported as a result of this event.The patient is a participant in the world-wide randomized antibiotic envelope infection prevention trial clinical study.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported the patient was seen in the clinic for routine exam and the site was noted to be well healed.

• Brand Name: EVERA S VR
• 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: 6469101
• Report Number: 3004209178-2017-07576
• Device Sequence Number: 583080
• Product Code: LWS
• UDI-Device Identifier: 00643169530324
• UDI-Public: 00643169530324
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2017

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: 02/28/2018
• Device Model Number: DVBC3D1
• Device Catalogue Number: DVBC3D1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2017
• Supplement Date Received by Manufacturer: 05/21/2017; 05/21/2017
• Initial Report FDA Received Date: 04/06/2017
• Supplement Report FDA Received Date: 08/09/2017; 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANTIBACTERIAL ENVELOPE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 66