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	Atrial Fibrillation (1729); Dizziness (2194); Shock from Patient Lead(s) (3162)
Date of Event	02/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: 0085 lead, implanted: (b)(6) 2004.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was inappropriately shocked due to atrial driven arrhythmias detected as ventricular fibrillation (vf) by the implantable cardioverter defibrillator (icd).The patient¿s family member called to report an inappropriate shock with the patient ending up in the emergency room (er).The patient¿s family member reports the patient having atrial fibrillation (af) and symptoms of dizziness.A follow up with the patient¿s healthcare provider yielded that the icd was reprogrammed and the issue was resolved.The icd remains in use.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: 7413888
• Report Number: 3004209178-2018-06978
• Device Sequence Number: 962985
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/14/2018
• 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: 02/14/2018
• Initial Report FDA Received Date: 04/10/2018
• 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: 6935-65 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 31 YR