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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2022

Event Type  Injury  

Event Description

It was reported that the patient's device displayed an error while attempting to place the device into mri mode.Upon further investigation system diagnostics recorded low impedances on the lead.Surgical investigation may take place at a future date to address the issue, investigation was unable to determine which of the leads attributed to the event.The allegation is against 1 of 2 lead; however, it is unknown which lead(s), therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: lead, model: 3186, udi: (b)(4), serial: (b)(6), batch: a000122824.

Manufacturer Narrative

Date of event estimated.The allegation is against 1 of 2 lead; however, it is unknown which lead(s), therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: lead, model: 3186, udi: (b)(4), serial: (b)(6), batch: a000122824.

Manufacturer Narrative

Date of event estimated.Correction: upon review, the decision is not reportable at this time.Surgical intervention will not be taken for the leads.Issue was resolved by replacing the ipg with a new model with updated mri capabilities thereby eliminating the need for lead replacement.Decision is not reportable.

Event Description

Additional information was received stating surgical intervention will not be taken for the leads.Issue was resolved by replacing the ipg on 01march2024 with a new model with updated mri capabilities thereby eliminating the need for lead replacement.Decision is not reportable.

• 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: 18335846
• MDR Text Key: 330607779
• Report Number: 3006705815-2023-08150
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

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 Expiration Date: 03/16/2024
• Device Model Number: 3186
• Device Lot Number: A000122824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/15/2023
• Supplement Dates Manufacturer Received: 03/01/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2022
• 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 IPG; SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 72 KG