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

Model Number	DVBB1D1
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.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 during implant of the implantable cardioverter defibrillator (icd) the programmer lost telemetry with the device.After the lead were connected to the device impedance readings could not be obtained.The lead were connected to the old device and impedance readings were normal.The physician did not use the device and a new device was successfully implanted.No 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: 6783329
• Report Number: 3004209178-2017-17066
• Device Sequence Number: 1361094
• Product Code: LWS
• UDI-Device Identifier: 00643169530300
• UDI-Public: 00643169530300
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2017

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: 02/28/2018
• Device Model Number: DVBB1D1
• Device Catalogue Number: DVBB1D1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2017
• 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
• Patient Age: 49 YR