MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE TRIAL LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3086

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

Patient Problems Fever (1858); Headache (1880); Nausea (1970)

Event Date 08/04/2018

Event Type  Injury  

Manufacturer Narrative

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 2.Reference mfr.Report:: 3006705815-2018-02078.It was reported the patient was experiencing high fever and vomiting.The patient presented at the emergency room (er) on (b)(6) 2018, with a headache.The physician decided to keep the patient overnight for observation.The trial leads were pulled a day early.The patient¿s lab results were normal/inconclusive and negative for infection.

Manufacturer Narrative

Corrected from device 2 of 2; reference mfr.Report:: 3006705815-2018-02078.Changed to device 2 of 2.Reference mfr.Report:: 1627487-2018-08055.

Event Description

Device 2 of 2.Reference mfr.Report:: 1627487-2018-08055.

• Brand Name: OCTRODE TRIAL LEAD KIT, 60CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: melody vincent ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 7837196
• MDR Text Key: 118899036
• Report Number: 3006705815-2018-02078
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734401555
• UDI-Public: 05414734401555
• 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,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2020
• Device Model Number: 3086
• Device Lot Number: A000053981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2018
• 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 1192 (X2), SCS ANCHOR
• Patient Outcome(s): Other
• Patient Age: 36 YR