MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL PROTECTA XT VR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	D314VRG
Medical Device Problem Code	High Capture Threshold (3266)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2019
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 implantable cardioverter defibrillator (icd) caused high right ventricular (rv) thresholds.The icd was explanted and replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).Analysis summary for pe#: (b)(4) analysis transaction id#: (b)(4); model#: d314vrg serial/lot#: (b)(4), methodology and techniques: the actual product involved in the event was evaluated.Electrical tests were performed.Mechanical tests were performed.Visual analysis was performed.Summary of analysis performed: during analysis, the following tests were performed: device - preliminary analysis, device - functional analysis, and device - longevity analysis.Results of analysis: based on analysis, it was determined that the product met specification.Product disposition: the returned product was retained in storage after the analysis concluded according to storage guidelines the product may be stored off site.If requested, the product may be returned to the patient provided after analysis the product was in a condition that it could be returned to the patient.Analysis information -- 2019-10-08 13:20:09 (b)(4), product id# (b)(4).The device was returned and analyzed.Analysis of the device revealed normal battery depletion.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTECTA XT VR
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• MDR Report Key: 9154022
• Report Number: 9614453-2019-03403
• Device Sequence Number: 2576414
• Product Code: LWS
• UDI-Device Identifier: 00613994678164
• UDI-Public: 00613994678164
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

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: 03/28/2012
• Device Model Number: D314VRG
• Device Catalogue Number: D314VRG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 27 YR