MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VERSA DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number VEDR01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Electro-Mechanical Dissociation (1826)

Event Date 11/21/2014

Event Type  Death  

Event Description

It was reported the patient is deceased and died the day of implantable pulse generator (ipg) implant procedure.Additional information obtained reported the cause of death as: pulseless electrical activity, acute on chronic coronary artery disease and chronic atherosclerosis.No further information was available from the cardiologists office and no information would be provided by the hospital.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

• Brand Name: VERSA DR
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4333308
• MDR Text Key: 5257022
• Report Number: 3004209178-2014-24019
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2014

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2016
• Device Model Number: VEDR01
• Device Catalogue Number: VEDR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2014
• Initial Date FDA Received: 12/16/2014
• Date Device Manufactured: 09/04/2014
• 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: 5076-58 LEAD, 5076-52 LEAD
• Patient Outcome(s): Death
• Patient Age: 00080 YR