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

Model Number	DVBC3D1
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/27/2019
Type of Reportable Event	Malfunction
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 implantable cardioverter defibrillator (icd) battery voltage was too low to be considered for implant and the device did not recover after sitting at room temperature.The device was never implanted and no patient was involved with this event.
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.The returned device indicated a junction current leakage in an integrated circuit.Hybrid analysis testing and evaluation determined that the gray bar status of remaining expected longevity and depleted battery voltage was due to high current drain in the hybrid.The analysis was narrowed to the l410 ic at the n3vdd node.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVERA¿ S 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: 8449166
• Report Number: 3004209178-2019-05966
• Device Sequence Number: 16231918
• Product Code: LWS
• UDI-Device Identifier: 00643169929852
• UDI-Public: 00643169929852
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2019

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: 04/14/2019
• Device Model Number: DVBC3D1
• Device Catalogue Number: DVBC3D1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1