MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL ADVISA MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number A3DR01

Device Problem Reset Problem (3019)

Patient Problems Muscle Stimulation (1412); Complaint, Ill-Defined (2331)

Event Date 08/22/2019

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 has felt poorly since they were at their chiropractors two weeks ago and electrical therapy was used on their left shoulder.Upon interrogation, it was found that implantable pulse generator (ipg) had a full electrical reset.The patient symptoms are likely related to the vvi 65 pacing.The ipg remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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.

Event Description

It was further reported that the patient experienced pectoral muscle stimulation.The implantable pulse generator (ipg) was programmed back to its original setting and symptoms resolved.

• Brand Name: ADVISA MRI SURESCAN
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9030071
• MDR Text Key: 159516454
• Report Number: 9614453-2019-03071
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2019

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/28/2016
• Device Model Number: A3DR01
• Device Catalogue Number: A3DR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 09/13/2019
• Supplement Dates Manufacturer Received: 09/13/2019; 10/10/2019
• Supplement Dates FDA Received: 09/13/2019; 10/11/2019
• Date Device Manufactured: 04/10/2015
• 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
• Patient Outcome(s): Required Intervention