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 07/02/2022

Event Type  Injury  

Event Description

It was reported that during device analysis the returned ipg was discovered to have lost communication with external devices on (b)(6) 2022.The ipg was then recovered on (b)(6) 2022 during a surgical procedure to explant the device.

Manufacturer Narrative

The reported event of no ipg communication was confirmed.A review of the ipg diagnostic logs revealed that the ipg was recovered the day of explant on (b)(6) 2022 after entering the service application condition state on (b)(6) 2022.Per event details, there was no report of any unrelated procedures that could have caused the service app condition that occurred on (b)(6) 2022.When the device recovers from the service app state, the data logs prior to the recovery are lost.Since the device entered the service app state on (b)(6) 2022, and the patient didn't report an unrelated procedure, it is inconclusive what caused the service app condition.

Manufacturer Narrative

Correction: h6 codes corrected to reflect updated investigation results.

Manufacturer Narrative

Correction: g3 on the previous report should have been (b)(6) 2023 rather than (b)(6) 2023.

• 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: 16380456
• MDR Text Key: 309595036
• Report Number: 1627487-2023-00384
• 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,Followup
• Report Date: 04/05/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2019
• Device Model Number: 6662
• Device Catalogue Number: 6662
• Device Lot Number: 6119117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 03/29/2023; 03/04/2023; 04/05/2023
• Supplement Dates FDA Received: 03/29/2023; 04/04/2023; 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2017
• 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