MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD, 3/4MM, 90 CM; SCS LEAD

Model Number 3149

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

Patient Problem Erosion (1750)

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

The reported event cannot be analyzed via laboratory testing.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

Device 3 of 4, reference mfr.Report# 1627487-2018-3754, 1627487-2018-3755, 1627487-2018-3758: it was reported the patient has leads protruding that can be seen through the skin due to erosion.Surgical intervention may be pending to address this issue.

Event Description

Device 3 of 4: reference mfr.Report# 1627487-2018-3754, 1627487-2018-3755, 1627487-2018-3758.Follow up information identified that scs system was explanted.An abbott representative was not present for the procedure.

• Brand Name: QUATTRODE LEAD, 3/4MM, 90 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
• MDR Report Key: 7433849
• MDR Text Key: 105593715
• Report Number: 1627487-2018-03756
• Device Sequence Number: 1
• Product Code: GZB
• 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: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2014
• Device Model Number: 3149
• Device Lot Number: 3880613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/16/2018
• Supplement Dates Manufacturer Received: 06/07/2018
• Supplement Dates FDA Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2012
• 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), EXTENSION; MODEL 3341 (2), EXTENSION; MODEL 3789, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 59 YR