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); Movement Disorder (4412)

Event Date 01/24/2024

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.Initial reporter phone number: (b)(6).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.

Event Description

It was reported that the patient's ipg became inoperable after an mri where the ipg was set to mri mode.Troubleshooting was unable to resolve the issue.

Event Description

Additional information received indicates that the patient underwent surgical intervention during which the ipg was explanted and replaced with no complications.

Event Description

Additional information received indicates that the patient may undergo surgical intervention to address the issue.

• 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: 18706940
• MDR Text Key: 335442411
• Report Number: 1627487-2024-00770
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: LH
• 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: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6660
• Device Lot Number: T00005267
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2023
• 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
• Patient Outcome(s): Other