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

Model Number	DDBB1D4
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	12/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
5076-45 lead implanted: (b)(6) 2016.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient experienced dizziness, during episodes that were thought to be sinus tachycardia or atrial fibrillation (af) with rapid ventricular response that the device determined to be ventricular tachycardia (vt).It was noted that an algorithm withheld therapy per programming.The implantable cardioverter defibrillator (icd) remains in use.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: 11226887
• Report Number: 3004209178-2021-01335
• Device Sequence Number: 11713617
• Product Code: LWS
• UDI-Device Identifier: 00643169720374
• UDI-Public: 00643169720374
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/14/2020
• 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: 12/30/2020
• Initial Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR