MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADVISA MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number A2DR01

Device Problems Battery Problem (2885); Appropriate Term/Code Not Available (3191)

Patient Problems Bradycardia (1751); Dizziness (2194); Chest Tightness/Pressure (2463); Palpitations (2467)

Event Date 05/11/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported by the patient to the health care professional that they are experiencing "skipped beats" and questioned if the implantable pulse generator (ipg) is working properly.The ipg remains in use.No 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.

Event Description

It was further reported that the patient experienced precordial pressure, lightheadedness and bradycardia.It was suspected that the implantable pulse generator (ipg) exhibited rising battery impedance.

• Brand Name: ADVISA MRI SURESCAN
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10108723
• MDR Text Key: 193407909
• Report Number: 3004209178-2020-09525
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00613994713650
• UDI-Public: 00613994713650
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/28/2014
• Device Model Number: A2DR01
• Device Catalogue Number: A2DR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2020
• Date Device Manufactured: 12/11/2012
• 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: 5086MRI58 LEAD, 5086MRI52 LEAD
• Patient Age: 90 YR
• Patient Weight: 87