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

Model Number	DDMC3D1
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Invalid Sensing (2293)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient had an elevated heart rate leading to t-wave oversensing (twos) and was shocked twice as a result.The lead remains in use.No patient complications have been reported as a result of this event.On (b)(6) 2018: it was further reported that about three months post implant of the patient¿s new implantable cardioverter defibrillator (icd) the patient received an inappropriate shock during an exercise period when hr (heart rate) was elevated and t-wave oversensing occurred.The icd did not withhold delivering shock therapy for the t-wave oversensing as the icd had determined it as a ventricular fibrillation (vf) episode.It was noted that all shock discriminators were on.The icd was reprogrammed and remains in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the device was not returned for analysis.However, performance data collected from the device was received and analyzed.Analysis of the device memory indicated t-wave oversensing associated with the right ventricular lead.Analysis of the device memory indicated unexpected delivery of ventricular tachyarrhythmia therapy.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVERA AF MRI S
• 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: 7473817
• Report Number: 3004209178-2018-09658
• Device Sequence Number: 10802497
• Product Code: LWS
• UDI-Device Identifier: 00643169717244
• UDI-Public: 00643169717244
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 05/15/2018

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: 06/14/2018
• Device Model Number: DDMC3D1
• Device Catalogue Number: DDMC3D1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 05/15/2018
• 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: 694765 LEAD, 407652 LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR
• Patient Weight: 79