MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SECURA VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	D224VRC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Purulent Discharge (1812); Fever (1858); Hemorrhage/Blood Loss/Bleeding (1888); Skin Discoloration (2074); Chills (2191); Discomfort (2330); Coma (2417); Valvular Insufficiency/ Regurgitation (4449); Swelling/ Edema (4577)
Date of Event	11/18/2009
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that about a week after the implantable cardioverter defibrillator (icd) was implanted the implant site was sore and had a pale discoloration.Several weeks later the patient had fever and chills.The patient went to the hospital.At the hospital it was observed that puss oozed from the implant site when pressure was applied.It was found that the patient had a staph infection.Antibiotics were administered, and the icd system was explanted.After the explant the patient had internal bleeding and more surgery was needed.The patient was in a coma for about one month.After waking up the patient remained in the hospital due to venous insufficiency in the brain, and swelling in multiple areas of the body including head and arms.The patient was eventually discharged, and later the icd system was replaced.
Additional Manufacturer Narrative
The initial reported event of infection was submitted via an alternative summary report.As the summary report has been revoked, this new information is therefore being submitted via a 30 day report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SECURA VR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 14163652
• Report Number: 3004209178-2022-05025
• Device Sequence Number: 5755262
• Product Code: LWS
• UDI-Device Identifier: 00613994446640
• UDI-Public: 00613994446640
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2009
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/20/2022

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: 10/28/2010
• Device Model Number: D224VRC
• Device Catalogue Number: D224VRC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/20/2022
• Date Device Manufactured: 05/08/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 6945-65 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Male