MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD WIDE SPACED, 60 CM; SCS LEAD

Model Number 3166

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.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.Manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 3 of 4.Reference mfr.Report# 1627487-2018-07966.Reference mfr.Report# 1627487-2018-08094.Reference mfr.Report# 1627487-2018-08098.It was reported the patient's lead was eroding through the skin.Surgical intervention may be taken at a later date to address the issue.

Event Description

Device 3 of 4; reference mfr.Report# 1627487-2018-07966, reference mfr.Report# 1627487-2018-08094, reference mfr.Report# 1627487-2018-08098.Additional information received identified the leads were repositioned on 10 september 2018 which resolved the issue.

• Brand Name: QUATTRODE LEAD WIDE SPACED, 60 CM
• Type of Device: SCS 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: taruna sharma ; 6901 preston road; plano, TX 75024 ; 9725269635
• MDR Report Key: 7826270
• MDR Text Key: 118546026
• Report Number: 1627487-2018-08096
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734406109
• UDI-Public: 05414734406109
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: 3166
• Device Lot Number: 5241620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2015
• 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: MODEL 3341 (2), SCS EXTENSION; MODEL 3789, SCS IPG
• Patient Outcome(s): Other