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

Model Number 6662

Device Problem Migration (4003)

Patient Problem Implant Pain (4561)

Event Date 03/06/2023

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined. .

Event Description

Related manufacturer reference number: 1627487-2023-01171 and 1627487-2023-01172.It was reported that the patient experienced ineffective therapy and pain at the ipg site.Troubleshooting revealed high impedance on both extension due to migration of the ipg.As a result, surgical intervention was undertaken on (b)(6) 2023 wherein the ipg was repositioned, and the extensions were explanted and replaced to address the issue.

• 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 16553053
• MDR Text Key: 311398290
• Report Number: 1627487-2023-01173
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067030023
• UDI-Public: 05415067030023
• 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
• Type of Report: Initial
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6662
• Device Catalogue Number: 6662
• Device Lot Number: T00004968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• 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 LEAD (X2)
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 100 KG