MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA

Model Number 37603

Device Problem Electromagnetic Interference (1194)

Patient Problem Confusion/ Disorientation (2553)

Event Date 02/06/2018

Event Type  malfunction  

Manufacturer Narrative

Refer to reg.Report 3004209178-2021-15307 for information regarding the related event.If information is provided in the future, a supplemental report will be issued.

Event Description

2021-oct-12 (b)(4): it was reported that the patient had an mri on (b)(6), 2018 and experienced sensations during the scan.No further information was provided.

• Brand Name: ACTIVA
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 12627604
• MDR Text Key: 281584231
• Report Number: 3004209178-2021-15308
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761071
• UDI-Public: 00613994761071
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 10/13/2021

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: Health Professional
• Device Expiration Date: 04/28/2015
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR