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

Model Number 3186

Device Problem Impedance Problem (2950)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2018

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.During the processing of this incident attempts were made to obtain complete patient information.

Event Description

Related manufacturer reference number: 3006705815-2020-33413.It was reported the system was unable to be placed into mri mode as there was an impedance problem with the leads.Therapy was not impacted, however due to the patient needing to undergo an mri, the leads are slated to be replaced.

Event Description

It was reported that the patient's leads were replaced.Therapy was restored following the procedure.

Manufacturer Narrative

A patient controller displayed an error message " mri not advised" while attempting to set ipg to mri mode was reported to abbott.The patient was asked to try to put the system into mri mode while in different positions.The ipg and leads were replaced.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• Type of Device: PERCUTANEOUS 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
• MDR Report Key: 11076275
• MDR Text Key: 223717022
• Report Number: 3006705815-2020-33414
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017246
• UDI-Public: 05415067017246
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2019
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000047637
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL OCTRODE LEAD KIT, 60CM LENGTH; MODEL OCTRODE LEAD KIT, 60CM LENGTH
• Patient Outcome(s): Other
• Patient Weight: 68