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 Swelling (2091); Fluid Discharge (2686)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturer¿s evaluation: the reported event of infection cannot be confirmed via laboratory testing.Sjm 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.(b)(4).

Event Description

Device 2 of 4.Reference mfr report: 1627487-2016-01732, 1627487-2016-01734 & 1627487-2016-01735.It was reported the patient was having drainage at the lead insertion site.Additionally, there was redness, warmth and swelling at the ipg site.The patient was sent to an infectious disease doctor and was prescribed antibiotics but the symptoms have not cleared up.Follow-up identified the patient's entire scs system was explanted.

• 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: 5568822
• MDR Text Key: 42373161
• Report Number: 1627487-2016-01733
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 3186
• Device Lot Number: 5301423
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other