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 02/09/2023

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.During processing of this complaint, attempts were made to obtain patient weight.

Event Description

It was reported the patient experienced the patient experienced pain at the ipg site due to ipg migrating in the pocket.As a result, surgical intervention occurred wherein the ipg was explanted and replaced to address the issue.

Manufacturer Narrative

The reported observation of ¿pain at ipg site, ipg migration¿ was not confirmed.A visual inspection of the ipg did note the suture anchors were damaged.The root cause as not ascertained.The root cause of pain at the ipg site could not be ascertained; there were no electrical anomalies observed during analysis that would have contributed to the observation.The damage sutures can result in the device not being secure in the ipg pocket.No x-ray of the device prior to explant was provided.Using clinicians programmer, ipg system impedance testing was within the expected range.The ipg was subjected to a functional test on automated test equipment (ate).This tester verifies the electrical performance of the control/communication circuitry, and output signal.All portions of ate testing passed.The ate test specifically tests the ipg output and system impedances integrity on all 16 electrodes including the ipg can connection.

• 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: 16521849
• MDR Text Key: 311059638
• Report Number: 1627487-2023-00935
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020260
• UDI-Public: 05415067020260
• 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: 05/02/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2020
• Device Model Number: 6662
• Device Catalogue Number: 6662
• Device Lot Number: 7532346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/10/2023
• Supplement Dates Manufacturer Received: 04/21/2023
• Supplement Dates FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2018
• 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: DBS BURR HOLE CAP X2.; DBS LEAD EXTENSION X2.; DBS LEAD X2.
• Patient Outcome(s): Other
• Patient Sex: Female