MAUDE Adverse Event Report: ABBOTT MEDICAL INFINITY¿ 5 IMPLANTABLE PULSE GENERATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 6660

Device Problem Wireless Communication Problem (3283)

Patient Problem Movement Disorder (4412)

Event Date 04/12/2022

Event Type  malfunction  

Manufacturer Narrative

Based on information obtained the device is included in the neuromodulation implantable pulse generator (ipg) unable to exit mri mode advisory notice issued by abbott on (b)(6) 2023.Fsca number is pending.

Event Description

Related manufacturer report number: (b)(4).It was reported the patient cannot exit mri mode.The issue was resolved via trouble shooting.Based on information obtained the device is included in the neuromodulation implantable pulse generator (ipg) unable to exit mri mode advisory notice issued by abbott on (b)(6)2023.Fsca number is pending.

Manufacturer Narrative

The fsca number is included in this report.A patient unable to disable mri mode and activate therapy was reported to abbott.Troubleshooting steps resolved the issue and therapy was reestablished.Based on the information received, the event is consistent with the loss of the bluetooth pairing bond while in mri mode.As a result of this finding, abbott is performing further investigation.

• Brand Name: INFINITY¿ 5 IMPLANTABLE PULSE GENERATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 17366189
• MDR Text Key: 319674297
• Report Number: 1627487-2023-03490
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020246
• UDI-Public: 05415067020246
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2021
• Device Model Number: 6660
• Device Catalogue Number: 6660
• Device Lot Number: 6903445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-07/07/2023-001-C
• Patient Sequence Number: 1
• Treatment: DBS BURR HOLE COVER.; DBS EXTENSION.; DBS LEAD.
• Patient Sex: Male