MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3189

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

Patient Problem Erosion (1750)

Event Date 03/09/2018

Event Type  Injury  

Manufacturer Narrative

In the event the device is returned to the manufacturer, 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.Sjm defers to the patient's physician regarding medical history.

Event Description

It was reported the lead site eroded.The patient underwent surgical intervention on (b)(6) 2018 where the lead was explanted.

Event Description

Device #1 of 2: reference mfr.Report: 1627487-2018-04167.Follow up information identified two leads were returned for analysis.It was confirmed only one lead had eroded through the skin, however both leads were explanted.

Manufacturer Narrative

Model 3189.The reported event cannot be analyzed via laboratory testing.

Event Description

Device #1 of 2: reference mfr.Report: 1627487-2018-04167.Upon device return to the manufacturer it was determined the leads are model 3189 and device information remains unknown.

Event Description

Device #1 of 2: reference mfr.Report: 1627487-2018-04167.Follow up information identiifed the patient reports the wound site has healed.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• 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: 7388196
• MDR Text Key: 104048212
• Report Number: 1627487-2018-03258
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/13/2018

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: 10/28/2011
• Device Model Number: 3189
• Device Lot Number: 2867112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 04/02/2018
• Supplement Dates Manufacturer Received: 04/05/2018; 05/11/2018; 09/04/2018
• Supplement Dates FDA Received: 04/27/2018; 05/30/2018; 09/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2009
• 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 3772, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 19 YR