MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 90CM LENGTH; SCS LEAD

Model Number 3189

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

Patient Problems Fever (1858); Post Operative Wound Infection (2446)

Event Date 06/15/2017

Event Type  Injury  

Manufacturer Narrative

In the event the device is returned to the manufacturer, the reported event cannot be analyzed 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.

Event Description

Device 1 of 5: reference mfr.Report#: 1627487-2017-03748, reference mfr.Report#: 1627487-2017-03749, reference mfr.Report#: 1627487-2017-03750 , reference mfr.Report#: 1627487-2017-03751.It was reported the patient was admitted to the hospital for infection.The patient also had a fever and was treated with oral and iv antibiotics.On (b)(6) 2017, the patient underwent surgical intervention wherein her entire scs system was explanted.

Event Description

Device 1 of 5, reference mfr.Report#: 1627487-2017-03748.Reference mfr.Report#: 1627487-2017-03749.Reference mfr.Report#: 1627487-2017-03750.Reference mfr.Report#: 1627487-2017-03751.Follow-up information revealed the patient's infection has resolved.

• Brand Name: OCTRODE LEAD KIT, 90CM 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: 6699602
• MDR Text Key: 79570922
• Report Number: 1627487-2017-03747
• 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
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: 3189
• Device Lot Number: 5256030
• Other Device ID Number: 05414734401715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2015
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 40 YR