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

Model Number	DVBB1D1
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Invalid Sensing (2293)
Health Effect - Clinical Codes	Complaint, Ill-Defined (2331); Shock from Patient Lead(s) (3162)
Date of Event	02/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient had been doing well but then felt poorly and was admitted after receiving multiple (b)(6) icd (implantable cardioverter defibrillator) inappropriate shocks for atrial arrhythmias.An echocardiogram showed the patient had low ejection fraction.The patient was treated with iv (intravenous) amiodarone and heparin and converted to sinus rhythm.The patient later had a svt (supra ventricular tachycardia) ablation procedure.The device remains in use.The patient is a participant in the world-wide randomized antibiotic envelope infection prevention trial clinical study.No further patient complications have been reported as a result of this event.

• Brand Name: EVERA XT 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: 6780741
• Report Number: 3004209178-2017-16746
• Device Sequence Number: 11166747
• Product Code: LWS
• UDI-Device Identifier: 00643169530300
• UDI-Public: 00643169530300
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 05/25/2017

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/14/2017
• Device Model Number: DVBB1D1
• Device Catalogue Number: DVBB1D1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2017
• Initial Report FDA Received Date: 08/09/2017
• 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; Life Threatening; Required Intervention
• Patient Age: 24 YR
• Patient Weight: 169