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

Model Number A2DR01

Device Problem Defective Alarm (1014)

Patient Problem Syncope (1610)

Event Date 07/10/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 305u23 tissue valve, implanted: (b)(6) 2010.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that by the patient that they "fainted" and then heard a sound "like a horn" from the implantable pulse generator (ipg) and then the patient "came to".The ipg remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: ADVISA 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10366430
• MDR Text Key: 201673378
• Report Number: 3004209178-2020-13441
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/05/2020

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: 06/28/2017
• Device Model Number: A2DR01
• Device Catalogue Number: A2DR01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 08/05/2020
• Date Device Manufactured: 01/09/2016
• 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: 5076-45 LEAD, 5076-52 LEAD
• Patient Outcome(s): Life Threatening
• Patient Age: 80 YR