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

Model Number 3186

Device Problem Low impedance (2285)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/20/2023

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The allegation is against one of two leads; however, it is unknown which lead(s), therefore, all potential components are being listed.Additional components potentially involved in the event: product family: scs, model: 3186, udi: (b)(4), serial: (b)(6), batch: a000145620.The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.

Event Description

Related manufacturer reference number: 3006705815-2024-01234, 3006705815-2024-01236.It was reported the patient¿s system was unable to enter mri mode due to low impedances and the patient experienced ineffective stimulation due to both leads migrating.X-rays confirmed the migration.Patient had fallen on 20 december 2023.Surgical intervention took place wherein one lead was explanted and replaced and one lead was repositioned to address the issues.It is unknown which lead had low impedances as such both leads are being reported.

• 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18707982
• MDR Text Key: 335403103
• Report Number: 3006705815-2024-01233
• Device Sequence Number: 1
• Product Code: LGW
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2024

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 Model Number: 3186
• Device Lot Number: A000145620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2023
• 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: SCS ANCHORS X 2; SCS IPG
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 136 KG