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 Hematoma (1884); Pain (1994); Weakness (2145); Numbness (2415)

Event Date 10/25/2017

Event Type  Injury  

Manufacturer Narrative

In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.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: 3006705815-2017-01680.The patient reported experiencing back pain, as well as numbness and weakness in both legs.As a result, the physician explanted both trial leads.Physician sent patient to the emergency room for mri and neurology consultation.

Event Description

Device 2 of 2.Reference mfr.Report: 3006705815-2017-01680.Follow up information identified the patient¿s care has been transferred to another physician.Patient status has not been provided to the manufacturer.

Manufacturer Narrative

Event date and explant date corrected.

Event Description

Device 2 of 2.Reference mfr.Report: 3006705815-2017-01680.For clarification, the patient experienced pain, and then numbness and weakness in both legs during the night of (b)(6) 2017.The physician explanted both trial leads and then sent the patient to the emergency room for mri and neurology consultation.Patient had a hematoma that spanned spinal column from t8-l2, and patient had a laminectomy that spanned the same vertebral columns.As of (b)(6) 2017, bilateral loss of motor function continues.Explant date of leads has been corrected.

• 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: joanne story ; 6901 preston road; plano, TX 75024 ; 9725264875
• MDR Report Key: 7034498
• MDR Text Key: 92102370
• Report Number: 3006705815-2017-01681
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2019
• Device Model Number: 3086
• Device Lot Number: A000044478
• Other Device ID Number: 05414734401555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2017
• 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: 70 YR