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

Model Number 6662

Device Problem Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

It was reported the patients ipg was nearing end of life.As a result, surgical intervention was undertaken wherein the ipg was explanted and replaced prior to it losing functions.

Manufacturer Narrative

Based on parameters obtained, technical services/product performance engineering confirmed the end of life calculations exhibit what the patient is experiencing, confirming normal device characteristics.Decision is not reportable.

• 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: 13115782
• MDR Text Key: 282957366
• Report Number: 1627487-2021-19422
• 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,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2020
• Device Model Number: 6662
• Device Catalogue Number: 6662
• Device Lot Number: 6659504
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2018
• 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: BURR HOLE CAP (X2); DBS EXTENSION (X2); DBS LEAD (X2)
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 91 KG