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 Code	Shock from Patient Lead(s) (3162)
Date of Event	03/20/2018
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 a review of the remote transmission indicated that the patient received inappropriate shocks and a lead integrity alert was triggered for the right ventricular (rv) lead due to lead impedance, oversensing, and sensing integrity counter (sic).There was also rv lead impedances warnings triggered for high pacing impedance and a rv lead noise warning triggered.Additionally,there were high rate non-sustained episodes noted on the interrogation report.A possible lead fracture was suspected.The rv lead was programmed off.It was also questioned why the implantable cardioverter defibrillator (icd) did not withhold the inappropriate shocks.The following day the rv lead was capped and replaced.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: 7459644
• Report Number: 3004209178-2018-08892
• Device Sequence Number: 11036551
• Product Code: LWS
• UDI-Device Identifier: 00643169530300
• UDI-Public: 00643169530300
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2018

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: 01/14/2018
• 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: 03/20/2018
• Initial Report FDA Received Date: 04/25/2018
• 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: THE 6945-65 LEAD
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 88 YR