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 Cerebrospinal Fluid Leakage (1772); Headache (1880); Nausea (1970); Vomiting (2144)

Event Date 02/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.(b)(4).

Event Description

It was reported during a trial lead implantation procedure the patient experienced a cerebrospinal fluid (csf) leak.The physician performed a blood patch to stop the csf leak after which, the lead was placed.The patient had effective therapy intra-operatively.However, post-operatively, the patient experienced headache, nausea and vomiting in turn, the patient was administered medication.Reportedly, the patient was asymptomatic the following day.

• 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: jennifer shepard ; 6901 preston road; plano, TX 75024
• MDR Report Key: 6390041
• MDR Text Key: 69439586
• Report Number: 3006705815-2017-00220
• 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: 02/14/2017

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: 01/17/2019
• Device Model Number: 3086
• Device Lot Number: A000034443
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/14/2017
• Initial Date FDA Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2017
• 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): Other
• Patient Age: 54 YR