MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO EVERA XT VR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number DVBB1D1

Device Problems Pocket Stimulation (1463); Protective Measures Problem (3015)

Patient Problem No Code Available (3191)

Event Date 08/24/2016

Event Type  Injury  

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 an audible alert sound.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 Description

It was reported that the patient felt a buzzing sensation.Possible pocket stimulation was suspected.Review of the implantable cardioverter defibrillator (icd) performance data found that the patient had magnet exposure.The device was reprogrammed.The device remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: EVERA XT VR
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7093814
• MDR Text Key: 94123393
• Report Number: 3004209178-2017-25417
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00643169017955
• UDI-Public: 00643169017955
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/14/2015
• Device Model Number: DVBB1D1
• Device Catalogue Number: DVBB1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 694765 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR