MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION 8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B

Model Number 6172

Device Problem Component Misassembled (4004)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A corrective/preventive action plan has been initiated by the manufacturer to address this issue.The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.

Event Description

This report is related to a (b)(6) patient.It was reported that intra-operative fluoroscopy indicated one of the contacts of an infinity dbs (deep brain stimulation) lead was lighter than the other contacts.The lead remains implanted, however no consequences or impact to the patient have been reported.

Event Description

Additional information received indicated the radiograph is confirmed to be the incorrect material; therefore, the material segregation issue described in fsca 1627487-10/16/18-001-r did affect this lead.The programming history review was performed and no evidence of therapeutic programming on the most proximal unsegmented electrode was found.Stimulation parameters did not activate the most proximal electrode and that electrode is constructed out of a known biocompatible material, aside from maintaining the programming restriction there is no additional action necessary for this patient.

• Brand Name: 8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B
• Type of Device: DBS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8065521
• MDR Text Key: 127066759
• Report Number: 1627487-2018-11979
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020680
• UDI-Public: 05415067020680
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2020
• Device Model Number: 6172
• Device Lot Number: 6359086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-10/16/18-001-R
• Patient Sequence Number: 1