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

Model Number	6170
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The 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 11oct2018.The listed serial number for the infinity dbs (deep brain stimulation) lead may contain an electrode that was not manufactured according to specification.No consequences or impact to the patient have been reported.
Event or Problem Description
Additional information received indicated the radiograph is normal; therefore, the material segregation issue described in fsca 1627487-10/16/18-001-r did not affect this lead.No additional action with the patient is necessary.

• Brand Name: 8CH INFINITY DBS LEAD KIT, 30CM, 0.5, B
• Common Device Name: DBS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 8069142
• Report Number: 1627487-2018-12023
• Device Sequence Number: 16675624
• Product Code: MHY
• UDI-Device Identifier: 05415067020635
• UDI-Public: 05415067020635
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/15/2020
• Device Model Number: 6170
• Device Catalogue Number: 6170
• Device Lot Number: 6320021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1627487-10/16/18-001-R
• Patient Sequence Number: 1