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); Movement Disorder (4412)

Event Date 08/24/2023

Event Type  Injury  

Event Description

Related manufacturer reference number: 1627487-2023-04443.It was reported the patient underwent a surgical procedure on (b)(6) 2023 where monopolar electrocautery was used.The patient¿s ipg was put into surgery mode prior to the procedure.After the surgery, the patient's ipg was unable to communicate, and the lead was damaged with cautery.Surgical intervention may take place at a later date.Investigation was unable to determine which of the leads attributed to the event.

Manufacturer Narrative

The allegation is against one of two leads; however, it is unknown which lead(s), therefore, all potential components are being listed.Additional components potentially involved in the event: product family: dbs, model: 6173, udi: (b)(4), serial: (b)(6), batch: 7859374.

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.

• 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 17765809
• MDR Text Key: 323628610
• Report Number: 1627487-2023-04442
• 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
• Type of Report: Initial,Followup
• Report Date: 09/25/2023

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 Model Number: 6662
• Device Lot Number: T00005018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/18/2023
• Supplement Dates Manufacturer Received: 09/20/2023
• Supplement Dates FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2022
• 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.; DBS BURR HOLE CAP.; DBS EXTENSION X 2.; DBS LEAD.
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 82 KG