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 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event is estimated.An inoperable implant was reported to abbott.The system may have not been set to surgery mode while the patient underwent an unrelated surgery where electro-cautery may have been used.A review of documentation supplied with the implant states that electro-surgery devices should not be used in close proximity to an implanted system.The device was not returned for analysis; however, data logs was received.Analysis of the record shows that the system was unable to successfully establish a connection with the clinician programmer.As a result, troubleshooting was performed in which the issue was resolved.Actions have been taken to prevent reoccurrence.

Event Description

It was reported that following an unrelated surgical procedure in which the system may not have been placed into surgery mode, the ipg could not communicate with external devices.As a result, troubleshooting was performed in which the issue was resolved.

• 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: 12302143
• MDR Text Key: 265847664
• Report Number: 1627487-2021-16153
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2022
• Device Model Number: 6662
• Device Catalogue Number: 6662
• Device Lot Number: 7475435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2020
• 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
• Patient Weight: 91