MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ADVISA SR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number A3SR01

Device Problems Inappropriate or Unexpected Reset (2959); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Fainting (1847); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132); Dizziness (2194)

Event Date 07/25/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experienced lightheadedness and an episode of ventricular tachycardia(vt) and may have been externally shocked in the emergency room.The implantable pulse generator (ipg) showed power on reset.The device was explanted and replaced.No further patient complications have been reported as a result of this event.It was later reported that the physician decided to upgrade the ipg due to the patient's cardiac arrest/ vt/ventricular fibrillation.

Manufacturer Narrative

Product event summary: performance data collected from the device was received and analyzed.Analysis of the device memory indicated a full electrical reset.Analysis of the device memory indicated a power on reset occurred.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ADVISA SR MRI SURESCAN
• 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 PUERTO RICO OPERATIONS CO.; 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: 7757991
• MDR Text Key: 116272534
• Report Number: 3004209178-2018-17580
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00643169402669
• UDI-Public: 00643169402669
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/04/2018

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/14/2017
• Device Model Number: A3SR01
• Device Catalogue Number: A3SR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2018
• Initial Date FDA Received: 08/07/2018
• Supplement Dates Manufacturer Received: 08/10/2018; 08/24/2018; 08/08/2018
• Supplement Dates FDA Received: 08/20/2018; 09/07/2018; 10/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2015
• 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: 5076-52 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR