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

Model Number 3186

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

Patient Problems Death (1802); Hematoma (1884); Seizures (2063)

Event Date 10/02/2018

Event Type  Death  

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 2: reference mfr.Report#: 3006705815-2018-02705.It was reported during an implant procedure on (b)(6) 2018, the patient had a cerebrospinal fluid (csf) leak (reference mfr.Reports: 3006705815-2018-02590 and 3006705815-2018-02591).Following the procedure, it was stated the patient was sent to er due to seizure type activity.A ct scan was performed and found a sub arachnoid hematoma.It was stated the patient remained in the hospital the entire time following the events.Follow-up information revealed the patient passed away on (b)(6) 2018.

Manufacturer Narrative

A patient experiencing a sub-arachnoid hematoma after lead implantation was reported to abbott.The physician has not attributed the event to implanted devices.The implantation of an scs device involves some risks commonly associated with surgery, such as a post-operative hematoma.The scs system was not returned for evaluation or disposal.The event information pertaining to this incident has been reviewed.Based on the information received, the extent to which surgical technique contributed to the sub-arachnoid hematoma cannot be ascertained nor can the cause of the reported incident be conclusively determined.

• Brand Name: OCTRODE 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 ; 9725264657
• MDR Report Key: 7996368
• MDR Text Key: 124729927
• Report Number: 3006705815-2018-02706
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017246
• UDI-Public: 05415067017246
• 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: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2020
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000063715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2018
• 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 (2), SCS ANCHOR; MODEL 3662, SCS IPG
• Patient Outcome(s): Death; Hospitalization