MAUDE Adverse Event Report: ABBOTT MEDICAL INFINITY¿ 5 IMPLANTABLE PULSE GENERATOR; DBS IPG

Model Number 6660

Device Problems High impedance (1291); Low impedance (2285)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/27/2021

Event Type  Injury  

Event Description

Related manufacturer reference number: 1627487-2021-18510.Related manufacturer reference number: 1627487-2021-18511.It was reported that the patient¿s therapy was affected due to impedance issue.Diagnostic revealed high and low impedances.As such, surgical intervention took place on (b)(6) 2021 wherein the extensions and ipg was explanted and replaced addressing the issue.Reportedly, issue was resolved and therapy was confirmed post operatively.

Manufacturer Narrative

Date of event is estimated.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 received indicates only the left extension and ipg was explanted.Device reported under 1627487-2021-18510 remains implanted.

• Brand Name: INFINITY¿ 5 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: 13114884
• MDR Text Key: 282960972
• Report Number: 1627487-2021-19421
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020246
• UDI-Public: 05415067020246
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2021
• Device Model Number: 6660
• Device Catalogue Number: 6660
• Device Lot Number: 7066769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2019
• 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
• Treatment: DBA BURR HOLE CAP (X2); DBS LEAD (X2)
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 75 KG