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

Model Number 3186

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

Patient Problems Erosion (1750); Discharge (2225); Post Operative Wound Infection (2446)

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.The manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 2 of 3.Reference mfr.Report: 1627487-2018-04632, reference mfr.Report: 1627487-2018-04732.It was reported (b)(6) the patient experienced drainage at the lead sites in addition to redness at the ipg site.The leads also eroded through the skin.Subsequently, surgical intervention was undertaken on (b)(6) 2017 to explant the system.The patient was prescribed antibiotics.

Event Description

Device 2 of 3, reference mfr.Report: 1627487-2018-04632, reference mfr.Report: 1627487-2018-04732.Further investigation identified cultures were taken; however the results remain unknown.In addition, the decision to explant was made as the infection had not resolved.

Event Description

Device 2 of 3; reference mfr.Report: 1627487-2018-04632, reference mfr.Report: 1627487-2018-04732.Follow-up identified cultures tested negative for the presence of organisms.In addition, the patient was hospitalized on (b)(6) 2017 due to the infection.

• 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: 7501079
• MDR Text Key: 107817123
• Report Number: 1627487-2018-04633
• 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,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2018

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: 09/27/2018
• Device Model Number: 3186
• Device Lot Number: 5655164
• Other Device ID Number: 05415067017246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/30/2018
• Initial Date FDA Received: 05/09/2018
• Supplement Dates Manufacturer Received: 05/28/2018; 05/30/2018
• Supplement Dates FDA Received: 05/30/2018; 06/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2016
• 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
• Patient Outcome(s): Hospitalization; Other