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

Model Number 6662

Device Problem Wireless Communication Problem (3283)

Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)

Event Date 05/17/2022

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

It was reported that, following radiation therapy, the patient's ipg was unable to communicate with external devices, deeming the ipg inoperable.In turn, surgical intervention was undertaken wherein the ipg was explanted and replaced, resolving the issue.

Manufacturer Narrative

The reported observation ¿ipg inoperable¿ was not confirmed or duplicated during analysis.The root cause of the observation was not ascertained.The ipg diagnostic logs showed the device appeared to be functioning normally on the observation date and was controlled/programmed after the event date.The device exhibited normal functionality during analysis which included communication testing with a clinician programmer.No programmer logs were returned from the field for review.The device 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 integrity.All portions of ate testing passed.

• 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: 14569154
• MDR Text Key: 293137017
• Report Number: 1627487-2022-03065
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020260
• UDI-Public: 05415067020260
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2021
• Device Model Number: 6662
• Device Catalogue Number: 6662
• Device Lot Number: 7096396
• 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: 08/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2019
• 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 Outcome(s): Other