MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION 8CH INFINITY DBS LEAD KIT, 30CM, 0.5, B

Model Number 6170

Device Problem Component Misassembled (4004)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2018

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 record is being proactively initiated based on the acknowledged implanted or unknown status which was in response to the medical device recall removal activity, letter dated oct 11, 2018.The listed serial number for the infinity dbs (deep brian stimulation) lead may contain an electrode that was not manufactured according to specification.No consequences or impact to the patient have been reported.

Manufacturer Narrative

Further information was received indicating this event was a duplicate and reported in manufacturer reference number 1627487-2018-11980.(b)(4).

• Brand Name: 8CH INFINITY DBS LEAD KIT, 30CM, 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: 8067237
• MDR Text Key: 127066264
• Report Number: 1627487-2018-12020
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020635
• UDI-Public: 05415067020635
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/24/2019

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: 01/02/2020
• Device Model Number: 6170
• Device Catalogue Number: 6170
• Device Lot Number: 6244627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2018
• 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