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

Model Number 6662

Device Problem Wireless Communication Problem (3283)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/16/2023

Event Type  Injury  

Event Description

Related manufacturer reference number:1627487-2023-00365.It was reported that the patient experienced side effects of speech arrest when reaching with their left arm, light-headed, lessening of tremor benefits.Reprogramming was unable to resolve the issue.As a result, surgical intervention was undertaken on (b)(6) 2023 wherein the right lead was explanted to address the issue.During the procedure, the ipg became unable to communicate with external devices.The device was confirmed to have been placed into surgery mode.Troubleshooting was unsuccessful.As a result, surgical intervention may be undertaken in the future.

Manufacturer Narrative

The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Additional information indicates surgical intervention was undertaken on (b)(6) 2023 wherein a right lead was implanted and the ipg and both extensions were explanted and replaced to address the issue.

Manufacturer Narrative

The report of inoperable ipg was confirmed.Analysis of the returned ipg found the device was set to surgery mode while the patient underwent lead revision surgery.A review of documentation supplied with the implant states that electro-surgery devices should not be used in close proximity to an implanted system.Analysis of the device found that the system is in service app mode and could not be recovered.

• 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: 16351666
• MDR Text Key: 309273230
• Report Number: 1627487-2023-00366
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2024
• Device Model Number: 6662
• Device Catalogue Number: 6662
• Device Lot Number: T00004239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487/06/02/2017/001-C
• Patient Sequence Number: 1
• Treatment: DBS BURR HOLE COVER (X2).; DBS EXTENSION (X2).; DBS LEAD.
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 82 KG