MAUDE Adverse Event Report: ABBOTT MEDICAL INFINITY¿ 7 IMPLANTABLE PULSE GENERATOR; DBS IPG

Model Number 6662

Device Problem Wireless Communication Problem (3283)

Patient Problems Failure of Implant (1924); Movement Disorder (4412)

Event Date 08/17/2023

Event Type  Injury  

Event Description

It was reported that the patient was unable to get their device out of mri mode.Troubleshooting was unable to resolve the issue.As a result, the patient underwent surgical intervention during which the ipg was explanted and replaced to resolve the issue.

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.

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.The report of ¿unable to connect¿ with the ipg was confirmed.Analysis of the returned ipg found that the root cause of ¿unable to connect¿ to the device was that the device was in mri mode.The event details stated that the patient had an mri days after implant and that the device was not taken out of mri mode after the procedure was completed.Uep was used to move device out of mri mode and bonding with cp was then successful.Device communicated with all lab utilities, passed all tests on the ate, and had no physical anomalies.

• Brand Name: INFINITY¿ 7 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: 17726614
• MDR Text Key: 323146620
• Report Number: 1627487-2023-04356
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020260
• UDI-Public: 05415067020260
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2023

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 Model Number: 6662
• Device Lot Number: T00005268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 11/08/2023; 12/12/2023
• Supplement Dates FDA Received: 11/16/2023; 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2023
• 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
• Patient Outcome(s): Other