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

Model Number 6662

Device Problem Battery Problem (2885)

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

Event Date 11/21/2023

Event Type  Injury  

Event Description

It was reported that diagnostics indicated the elective replacement indicator (eri) triggered earlier than intended.Surgical intervention was undertaken during which the ipg was explanted and replaced.

Manufacturer Narrative

Date of event is estimated.

Manufacturer Narrative

The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.

• 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: 18646799
• MDR Text Key: 334616192
• Report Number: 1627487-2024-00632
• Device Sequence Number: 1
• Product Code: MHY
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

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: 02/07/2024
• Device Model Number: 6662
• Device Lot Number: A000122174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• 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
• Treatment: DBS BURR HOLE CAP (2).; DBS EXTENSIONS (2).; DBS LEAD (2).
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 77 KG