MAUDE Adverse Event Report: ABBOTT MEDICAL INFINITY¿ 5 IMPLANTABLE PULSE GENERATOR; DBS IPG

Model Number 6660

Device Problem Wireless Communication Problem (3283)

Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388); Movement Disorder (4412)

Event Date 11/21/2023

Event Type  Injury  

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 22 june 2023.B3-date of event is estimated.

Event Description

It was reported the patient was not able to exit from mri mode after an mri.Next course of action is currently unknown.

Manufacturer Narrative

H6 - adverse event problem - the clinical codes were corrected to reflect dbs patient symptoms.

Manufacturer Narrative

A patient unable to disable mri mode and activate therapy was reported to abbott.Troubleshooting steps did not resolve the issue.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.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: INFINITY¿ 5 IMPLANTABLE PULSE GENERATOR
• Type of Device: DBS IPG
• 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: 18333070
• MDR Text Key: 330547813
• Report Number: 1627487-2023-05889
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020246
• UDI-Public: 05415067020246
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2022
• Device Model Number: 6660
• Device Lot Number: 7333082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2020
• 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 CAP.; DBS LEAD.; EXTENSION.
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 68 KG